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Business Development

Last updated: 10:52 27/03/2012

Business Development Director – Northern Europe

Reference number: 1976 Apply for this job Apply for this job »
Type: Permanent, full time Location: Field based in Germany

Job Description

Our client offers competitive compensation and additional benefits, together with career growth opportunities and more. 

 Background:

 Our client is the leading provider of enterprise imaging and interoperability solutions.  Our client’s solutions facilitate the sharing of images to create a more effective and efficient electronic healthcare experience for patients and physicians. 

 An integral component of our client’s organisation is the Clinical Trials Division, whose solutions and services are used by its clients to improve the execution of Clinical Trials and Subject Registries.

These solutions provide the capability to:

·         allow access by different user populations: subjects, sites, specialists, monitors, etc...

·          enable  acquisition of clinical data via a broad range of modalities

·          apply workflow to these data: review, monitoring, quality control, adjudication etc...

·         report on and analyse the data

·         route the data to process stakeholders

·         store the data or move the data into other systems and workflows

Our client’s Clinical Trials Division is rapidly expanding and achieved 100% growth in 2011, taking it to the Top Tier of solutions providers in the eClinical space.  To continue this rapid acquisition of market share the Division is now adding an additional Business Development Director to its Regional Sales Organisation, with responsibility for Northern Europe (East): Germany, Austria, Eastern Europe & Russia.

 Job Summary:

 To promote and sell the Clinical Trials Division's portfolio of solutions within a defined geographical region. Develop and execute territory plans according to company policy, which will include strategic and tactical sales planning.  Identify, qualify, demonstrate and present product capabilities to customers and prospects to increase sales and market share. Increase sales, improve customer satisfaction, maintain existing accounts and develop new business opportunities and revenue streams while contributing to the Division's success.

 Reports to the Regional Sales Manager, Europe/Asia Pacific

  The Role:

 •Meet or exceed all assigned quotas for sales of Division applications and components.

 •Develop business funnel/pipeline and ensure proper territory management.

 •Ensure proper total qualification of prospects inclusive of project-specific data collection and analysis for needs identification.

 •Manage and facilitate all solution presentations and demonstrations in assigned territory

 •Participate in and manage contract negotiations.

 •Develop sales strategies to ensure market share growth and success.

 •Perform accurate and timely territory and pipeline reporting as defined.

 •Gather and analyse market intelligence providing ongoing opportunity/threat analysis.

 •Identify and manage cross-functional department resource allocations to the sales cycle.

 •Plan, execute, and attend regional/national trade shows and seminars with assistance from regional and corporate resources.

 •Analyse customers’ needs and recommends solutions that best meet customers’ requirements.

 •Quote prices and terms, generate proposals, and prepare sales contracts for business obtained.

 •Prepare reports of business transactions, maintain up-to-date and accurate account profiles and keep expense accounts.

 •Enter new customer data and other sales data for current customers into our client’s customer relationship management system.

 •Maintain effective communications within and between various functional departments.

 •Perform special projects, tasks and studies as assigned by management.

Experience/Qualifications required

Skills and Attributes:

 ·         Domiciled On-Territory (Germany)

 Language Skills:

 ·         English and German speaking

 Experience:

 ·         Experience of Clinical Trial environment

·         Experience of eClinical solutions

·         Experience of Information Technology sales

·         Minimum of 5 years of direct sales experience

 

BUSINESS DEVELOPMENT MANAGER/DIRECTOR (BASED ON EX

Reference number: 1919 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex

Job Description

The company:

Our client is an eClinical software and mobile appliances provider who offers a platform for eTrial design, paper and eData capture, monitoring, coding, data management and reporting. Their unique architecture uses distributed computing and mobile technologies to provide the freedom to manage any type of data type, for any protocol, anywhere.  It is purpose-built to respond on-demand to the dynamic needs of study teams: 

¡  Support both simple and complex protocols right out of the box

¡  Operate globally wherever investigators and patients are located

¡  Incrementally go live, speeding study start up

¡  Execute amendments without system downtime or site interruption

¡  Analyze results through real-time reporting of global clinical data

General Description:

This position will be responsible for developing and closing sales of their EDC product. It will be responsible for all parts of the sales process: generation and development of leads, inside and outside sales calls, tailoring of presentations and proposals to specific customer needs and facilitation of proposals through customers’ approval processes.

The successful candidate will be a relentless new business “hunter” with established connections in the pharmaceutical, biotechnology or life sciences technology sales marketplace.

Core responsibilities:

 The Business Development Manager will perform activities from lead generation to sales closure in line with quarterly and annual sales targets and quotas.

¡  Prospect (i.e., “hunt”) for new account, focusing on areas of competitive differentiation, maintaining clear account records of points of contact, potential budgets, etc.

¡  Qualify and develop leads into closed technology sales: on-premise licensing, software-as-a-service licensing and professional services sales

¡  Manage tailoring of individual account plans, inclusive of proactive customer proposals and prepared responses to customer RFIs, RFPs and RFQs

¡  Manage customer expectations in line with value proposition and capabilities

¡  Monitor industry trends and quickly adapt to changing developments

¡  Comply with the Sales Operations business practices regarding capture and reporting of opportunities and sales.

Experience/Qualifications required

Basic qualifications and experience:

¡  Bachelor’s degree in Business Administration, Technology or Marketing (or equivalent industry experience).

¡  Demonstrated ability to build and maintain a strong sales funnel

¡  Demonstrated experience directly selling software and information services-based solutions in R&D divisions of pharmaceutical, biotech or life sciences organisations

¡  Demonstrated experience selling at multiple levels and entry points into life sciences organisations: clinical, IT and financial—from line manager to executive

¡  Proven track record of consistent quota achievement

¡  Demonstration of excellent written and oral communication skills, including the ability to tailor presentations and proposals to specific customer needs

¡  Willingness to travel 20-40% (to see customers, attend conferences, etc.)

 Preferred qualifications and experience:

¡  Experience selling electronic data capture (EDC) or clinical data management system (CDMS) technology

¡  Experience selling Software-as-a-Service (SaaS), Cloud Computing, or Application Service Provider (ASP) technology

¡  Familiarity with Internet-based, mobile or appliance technologies

¡  Educational background (or equivalent experience) inclusive of medicine, biology, biotechnology or similar field

¡  Ability and desire to work in an entrepreneurial environment

Clinical

Last updated: 10:11 21/12/2012

Senior Clinical System Programmer

Reference number: 1988 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based in Marlow, UK

Job Description

Summary:

 Working within an expanding group of Data Managers and Programmers worldwide, the successful candidate will develop EDC systems used on Clinical studies.  On a daily basis the successful candidate will work closely with Data Managers, reviewing specifications and providing technical input to develop EDC solutions.  Alongside the Data Manager the successful candidate will  work with other groups such as Clinical Research functions and Biostatistics to  ensure that the EDC system meets the needs of all and is of high first time technical and general quality. 

 As needed the successful candidate will work with other members of Clinical Programming to progress departmental initiatives and training.

 The Role:

  • Under the direction of management leads the design, development, validation, implementation, and provides ongoing support of electronic systems e.g., Electronic Data Capture (EDC), reporting/business intelligence tools (e.g., Business Objects, Spotfire) and programs (e.g., SQL, PL/SQL) according to the study specifications (e.g. Protocol, data Management Plan, Edit Check Specifications).
  • Analyse Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in clinical studies. 
  • Assist in the validation (self QC or peer review) of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements.
  • Provide leadership and content expertise for programming activities in support of Global Development to effectively manage data capture, review and database lock activities
  • Participates in team discussions around process improvements.
  • Support Corrective Action and Preventive Action initiatives.
  • Where required support the Computer System Validation activities associated with the development and roll-out of new systems or components.
  • Where required provide support to Departmental initiatives around training, process improvements and novel solutions to be used within the EDC system.
  • This position has matrixed responsibility to Clinical Data Management, Clinical Programming, Statistical Programming, Biostatistics, and the Clinical Research functions as well as external vendors, to enable the analysis and implementation of clinical information technology solutions.

Experience/Qualifications required

Skills and Attributes:

  • Ability to effectively interact with and influence others without direct reporting relationships
  • Technical abilities and skills in analysis, design, specification and programming of computer systems
  • Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
  • Analytical, problem solving and technical skills
  • Knowledge of Clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
  • Planning, organisational, and project management skills
  • Excellent communication skills
  • Negotiation skills
  • Conflict management skills
  • Attention to detail with high quality outputs
  • Computer skills (word processing, spreadsheets, graphics, PowerPoint)
  • Working knowledge of industry standards related to clinical study data management activities would be desirable (eCRF design, data standards and database design etc.)
  • Ability to travel 5%

 
 Experience:

  • Previous experience of leading eCRF builds within a clinical programming organisation, preferably within a medium-large pharmaceutical company or CRO.
  • Previous experience of working with EDC systems.  Experience with Medidata’s Architect and / or with Oracle’s Central Designer is highly desirable  Previous  experience of working with Reporting/Business Intelligence Tools (e.g. Business Objects, Spotfire) would be advantageous

 Qualifications:

 Degree or equivalent experience in Computer Science, Life Science or related field

Senior Clinical Data Manager

Reference number: 1980 Apply for this job Apply for this job »
Type: Permanent, full time Location: Marlow, UK

Job Description

Summary:

 The successful candidate must conduct his/her work activities in compliance with all of our client’s internal requirements and with all applicable regulatory requirements. Our client’s internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

 The Senior CDM (Clinical Data Manager) within Clinical Data Management will provide specialised knowledge and detailed attention to carry out data management data review activities in support of one or more clinical research studies. The position is responsible for-

 Working within clinical study teams as an extended team member.

Executing the clinical data management operations against project timelines, and any other priorities.

Using defined department metrics as a framework for timely and quality clinical data management deliverables.

Collaborating with peers within and outside the organisation to pro-actively manage data availability and integration.

Acting as a Lead Data Manager as determined by ability and proficiency level in essentials skills.

 Jobs Supervised (Titles):

Direct: None

Indirect: Clinical Data Coordinators, Clinical Data Integration Programmers, Clinical System Programmers, Medical Coding Specialists

 Key interfaces:

Routine contacts with Development Operations and Therapeutic Area Staff.

External interfaces include:  Various Contract Research Organisations and other vendors for data services (e.g. Reading Centres, Central Laboratories, Phase I units)

 The Role:

 KEY DUTIES AND RESPONSIBILITIES:

Lead Data Manager

Responsible for the role which includes executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams. Training of study site personnel in CRF completion, and data clarification processes. Coordination of all Data Management Data Review activities and any other Clinical Study Team Data Review (e.g. Masked Data Review). Ensuring completion of all activities leading to the Study Database Lock.

Study Data Manager

Responsible for the role which includes the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan. Initiation and management of the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.

Study Data Associate

Assist with the role which includes development of clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standards. Leadership of user acceptance testing activities of technologies implemented at a study level.

Clinical Study Team Member

Assist with the role which includes representation of the clinical data management and programming organisation in one or more clinical study teams.

Client personnel / Subject Matter Expert

Include implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks. Delivering training to clinical data management and other departments, as necessary. Report process gaps and potential misconduct during clinical studies to management. Support Corrective Action and Preventive Action initiatives.

Experience/Qualifications required

Skills and Attributes:

 Knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials

  • Knowledge of Research and Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
  • Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
  • Ability to effectively interact with and influence others without direct reporting relationships
  • Ability to multi-task and prioritise
  • Planning, organisational, and project management skills
  • Document writing skills
  • Attention to detail with high quality outputs
  • Negotiation skills
  • Conflict management skills
  • Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality
  • Ability to meet challenging milestones
  • Analytical and problem solving skills
  • Computer skills (word processing, spreadsheets, graphics, PowerPoint)

 Ability to travel 5%.

 Experience:

 ·         Previous work experience within a clinical data management organisation, preferably within medium-large pharma or CRO.

 Qualifications:

 ·         Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field.

Senior Clinical Scientist

Reference number: 1978 Apply for this job Apply for this job »
Type: Permanent, full time Location: Basingstoke, UK

Job Description

Summary:

 Leads the study team to design, develop and deliver the clinical study; Authors protocols, ICFs and study related plans developed.

 The Role:

 Responsible for the clinical review and approval of Case Report Forms (electronic as applicable) and provides clinical input into corresponding completion guidelines.

Oversees the management of CRO activities and other clinical vendors to ensure the quality is consistent with requirements; Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.

Develops and monitors budget for clinical development program and may negotiate budgets and contracts with CROs, investigative sites (as applicable) and vendors.

Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities; May mentor other Study Managers.

Experience/Qualifications required

Experience:

 • Generally varied experience in clinical research within a pharmaceutical company or CRO or similar organisation

 Qualifications:

 • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.

Clinical Research Associate

Reference number: 1974 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Basingstoke, UK , office based

Job Description

Role/Purpose

1.    Be responsible for the set-up, co-ordination, monitoring and closeout of national and international clinical studies

2.    To conduct clinical research activities to time and within budget

3.    Be responsible for ensuring that studies are conducted to the required GCP, regulatory, SOP and quality standards. 

4.    To ensure both our client’s and its clients’ interests are presented and   maintained to a highly professional standard

1.    General Responsibilities

a.    Ensure all clinical trials comply with our client’s SOPs, ICH/GCP, Statutory Instrument, EU Directive and all regulatory requirements

b.    Monitor and adhere to study budgets

c.    Prepare and monitor study plans and timelines where required

d.    Plan, identify and conduct pre-selection visits on suitable primary and secondary care centres to join our client’s network across the UK and Europe

e.    Liaise with the Project Manager as required to ensure a good level of  awareness on study issues and agreement to study commitments

f.     Ensure regular communication of clinical trial issues and progress to our client’s clinical study team

g.    Predict difficulties and resolve unexpected problems or delays involving internal/external contacts as appropriate.

h.    Produce regular and ad hoc reports and presentations on the progress of clinical trial activities as requested

i.      Manage the preparation, review  and distribution of study documentation as required

j.     Ensure all regulatory, insurance, ethical requirements and investigator agreements are in place for each Investigator centre prior to site initiation

k.    Co-ordinate the conduct of an investigator meeting or advisory board at clients request and be able to present study information on the protocol or guidance on GCP as necessary.

l.      Assist the Directors  or Clinical Project Managers with reports, feasibility, presentations and attendance at client or supplier meetings as requested

2.    Study conduct

a.    Oversee and monitor the management of clinical trials by regular investigator site / other third parties where they are involved

b.    Plan and conduct accompanied visits as agreed with the Clinical Research Manager

c.    Monitor recruitment rate, maintain patient tracking and take initiatives to ensure targets are met.

d.    Ensure that a high quality safety monitoring process is operated and that procedures for reporting adverse events and serious adverse events are strictly adhered to.

3.    Study close

a.    Ensure that all study activities are completed according to the study plan in line with current SOPs

b.    Ensure the study is archived according to the sponsor or our client’s requirements

4.    General

a.    Remain up to date with therapeutic knowledge, current medical practice, the clinical research environment and pharmaceutical regulations and guidelines in order to ensure consistent best practice across all activities

b.    Contribute in review of standard operating procedures

c.    Carry out any additional duties as necessary to facilitate the development of our client’s business as a whole

 

Experience/Qualifications required

Good intellectual, organisational, planning, and interpersonal skills.

Self motivated, flexible, diplomatic and able to show initiative

Excellent communicator, able to complete tasks to deadlines and provide attention to detail

Team player

Willing to travel and spend several consecutive nights away from home

Full driving licence

 Experience:

 A minimum of 6-12 months experience involved in clinical research activities

 Qualifications:

 Life sciences degree or suitable nursing qualification

Senior Clinical Research Associate

Reference number: 1973 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Field based - Madrid or Barcelona

Job Description

Summary:

 Administration and full site responsibility for clinical studies according to Company SOPs, ICH-GCP and local regulations.

May act as mentor for less experienced CRAs.

Ensures clinical trials are monitored such that subjects’ rights, safety and well-being are protected and the clinical trial data are reliable.

 

The Role:

 

Job duties and responsibilities:

 

Involved in more complex clinical trials.

Acts as a member of the project team with the goal to contribute towards efficient management of trials.

Assists the project managers in the preparation and review of protocols and informed consent forms.

Contributes to CRF design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).

Involved in recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the project manager.

Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department.

Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.

Experience/Qualifications required

Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.

Performs initiation visits: trains investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICHGCP and Company SOPs.

Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational

product/biological samples/supplies accountability.

Communicates effectively with site personnel, including the principal investigator, and Company management to relay protocol/study deviations and ensure timely implementation of corrective actions.

Develops and maintains good working relationships with investigators and study staff, serving as an ambassador to promote the Company's high quality and ethical image.

Maintains study tracking, in accordance with the demands of the study.

Performs data management review, including in-house CRF review, and alerts project managers and data managers to emerging issues with CRF completion.

Identifies and processes Serious Adverse Events according to the procedures defined by the study team.

Demonstrates understanding of the SAE reporting process to regulatory authorities.

May write SAE narratives to support pharmacovigilance activities.

Liaises with data management to resolve data discrepancies and ensure all data management study goals are met.

Prepares and performs closeout visits according to the protocol, local laws, ICH-GCP and Company SOPs.

Undertakes feasibility work when required.

Prepares accurate and timely visit reports from all types of visits.

May be involved in preparation of status reports for clients.

Functions as a mentor, assisting with the training and developing of less experienced CRAs via shadow or co-monitoring visits.

Assists with the development of SOPs.

Performs other duties as assigned by management.

Travels as necessary according to project needs.

Clinical Research Associate II

Reference number: 1972 Apply for this job Apply for this job »
Type: Permanent, full time Location: Madrid Spain - office based

Job Description

Summary:

 The job holder will perform the clinical monitoring aspect of designated projects in accordance with Company SOPs.

 The Role:

 Responsibilities will include managing clinical monitoring activities in addition to the ownership of investigator sites, including investigator/site selection, collating regulatory documentation, initiation and monitoring (source data verification, drug accountability and data collection) in accordance with ICH GCP guidelines.

  Skills:

 Excellent interpersonal, verbal, and written communication skills, (including experience in making presentations).

Client focused approach to work.

Ability to manage multiple and varied tasks and prioritise workload with attention to

Experience/Qualifications required

 Experience:

 Solid previous CRA experience in clinical research.

  Qualifications:

 Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification/experience.

 

Clinical Research Associate 2

Reference number: 1971 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Field based in Spain

Job Description

Summary:

 We are assisting this CRO to fill a field based CRA vacancy in Spain, ideally based in Madrid or Barcelona. This is a 12 months fixed-term contract initially, but might lead to a permanent position.

 The successful candidate will take on the following responsibilities:

 Administration and full site responsibility for clinical studies according to SOPs, ICH-GCP and local regulations.

 Ensures clinical trials are monitored such that subjects’ rights, safety and well-being are protected and that the clinical trial data are reliable.

 The successful candidate will also be involved in more complex clinical trials.

 The Role:

 Acts as a member of the project team with the aim of contributing towards the efficient management of trials.

 Assists the project managers in the preparation and review of protocols and informed

consent forms.

 Contributes to CRF design and clinical trial document development as they pertain to

clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).

 Involved in recruitment of potential investigators, preparation of EC/IRB submissions,

notifications to regulatory authorities, translation of study related documentation,

organisation of meetings and other tasks as instructed by the project manager.

 Negotiates investigator budgets and assists with the execution of site contracts with

support from the legal department.

 Oversees all aspects of study site management to ensure high quality data resulting

in consistently low query levels and in good Quality Assurance reports.

 Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.

 Performs initiation visits: trains investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH/GCP and SOPs.

 Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability.

 Communicates effectively with site personnel, including the principal investigator, and  management to relay protocol/study deviations and ensure timely implementation of corrective actions.

 Develops and maintains good working relationships with investigators and study staff, serving as an ambassador to promote our client’shigh quality and ethical image.

 Maintains study tracking, in accordance with the demands of the study.

 Performs data management review, including in-house CRF review, and alerts project

managers and data managers to emerging issues with CRF completion.

 Identifies and processes Serious Adverse Events (SAE) according to the procedures defined by the study team.

 Demonstrates understanding of the SAE reporting process to regulatory authorities.

 May write SAE narratives to support pharmacovigilance activities.

 Liaises with data management staff to resolve data discrepancies and ensure all data management study goals are met.

 Prepares and performs close-out visits according to the protocol, local laws, ICH-GCP and SOPs.

 Undertakes feasibility work when required.

 Prepares accurate and timely visit reports from all types of visits.

 Maybe involved in preparation of status reports for clients.

 Functions as a mentor, assisting with the training and developing of less experienced CRAs via shadow or co-monitoring visits.

 Assists with the development of SOPs.

 Performs other duties as assigned by management.

 Travels as necessary according to project needs.

Experience/Qualifications required

Skills:

 Demonstrates a strong working knowledge of ICH-GCP, relevant SOPs and regulatory guidance, as well as the ability to implement.

 Resolves project related problems and prioritises workload to meet deadlines with

little support from management.

 Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.

 Understands the basics of clinical trials methodology.

 Demonstrates a working knowledge of protocols and indications being studied.

 Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments and positive interactions with customers and colleagues.

 Demonstrates good communication skills (written and verbal).

 Demonstrates good interpersonal skills.

 Collects data of a consistently high standard.

 Demonstrates mentoring skills.

 Conducts formal presentations to a wide variety of audiences including colleagues,

investigative staff and clients, with proficiency.

 Provides accurate and timely administration.

 Acquires and demonstrates a good knowledge of the company.

 Works with minimal supervision.

 Possesses basic understanding of financial management and clinical trial budgets.

 Possesses practical knowledge of IT tools and systems used by the company.

 Demonstrates flexibility.

 Ability to drive and availability for domestic and international travel, including overnight

stays.

 Language Skills:

 English and Spanish

 Experience:

 Demonstrated experience as CRA either in CRO or pharmaceutical industry or investigational site.

 Qualifications:

 Graduate, postgraduate, or equivalent, ideally in a scientific or healthcare discipline.

Oncology Team Leader

Reference number: 1966 Apply for this job Apply for this job »
Type: Permanent, full time Location: Harlow, Essex

Job Description

The Role:

 Responsibilities:

 ·         Provide direction and guidance to the Biology teams working on the projects, to meet development timelines and milestones.

 ·         Help to coordinate the work of multiple in vitro and in vivo contract research establishments.

 ·         Provide input into the development, and implementation, of in vitro and in vivo pharmacology and pharmacodynamic assays for novel oncology targets.

 ·         Help to supervise the development of biomarker assays, as indicators of efficacy and for translational medicine studies to select responders in a clinical setting. 

 ·         Collection and interpretation of data, preparation of reports and delivery of presentations internally and at project meetings with other collaborators.

 ·         Maintaining an up-to-date understanding of scientific developments within appropriate fields.

Experience/Qualifications required

Skills:

 Candidates should be familiar with genomic and proteomic profiling technologies, biochemical and cellular pharmacology and other basic molecular and cell biology skills. The successful candidate will have the ability to multitask and drive projects, working across multiple disciplines in a matrix organisation. Excellent written and verbal communication skills and the ability to clearly communicate scientific objectives and project results are required.

Experience:

 The candidate should have 8 to 10 years experience, which includes management of people and working within multidisciplinary teams. Previous experience in the field of oncology translational medicine, biomarker discovery, and drug development is desirable.

 Qualifications:

 PhD degree.

Clinical Trial Co-ordinator

Reference number: 1959 Apply for this job Apply for this job »
Type: Permanent, full time Location: Brussels, Belgium

Job Description

Background:

 Our client is actively recruiting for a Clinical Trial Co-ordinator to join its expanding global company in Belgium. This is a  permanent, office based opportunity. By working for our client you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. 

 Summary:

 Due to a period of sustained expansion, a number of outstanding career opportunities have arisen within the Company, including the need for a talented Clinical Trial Co-ordinator to join its experienced team.

 The Role:

 Ensure administrative work of clinical trials is satisfactorily carried out: create Investigator Files and other study information, booklets, worksheets, etc.

  • Ensure timely translation and validation process of study materials (e.g. patient diaries, instructions, IC)
  • Provide investigators with all forms and lists to start the site evaluation and site validation (initiation and start of study information)
  • Ensure timely ordering of study tools
  • Preparation of ethical and regulatory submissions
  • Ensure protocol initiation processes 
  • Organisation and documentation of regular study meetings 
  • Organisation and documentation of local investigators meetings 
  • Provide professional presentation of study materials for CRA and investigator training
  • Archiving of processes, including electronic SORF and Trial Master File

Experience/Qualifications required

Skills:

  • Good knowledge of the clinical trial process 
  • Strong organisational and communication skills 

 Language Skills:

  • Fluency in Dutch and French languages (written and spoken)
  • Fluency in English (written and spoken)

 Experience:

  • Previous experience in a similar role would be highly advantageous

 Qualifications:

 High school degree or equivalent

 Company Information:

Our client is a UK-based, dynamic privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. It has been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over a decade. The Company prides itself in providing high quality, flexible and professional services and solutions to its clients. The Company has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Company employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of clinical trials across the full life-cycle of the drug development process from the CRO perspective. The Company has strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. The Company offers a competitive salary and rewards package. 

Clinical Research Associate

Reference number: 1958 Apply for this job Apply for this job »
Type: Permanent, full time Location: Brussels, Belgium

Job Description

Background:

 Our client is actively recruiting for clinical professionals to join its expanding global company.  By working for our client you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. In the past 12 months, our client company has expanded into 17 new countries with offices opening across the globe. Our client offers a competitive salary and rewards package.

Summary:

 The Clinical Research Associate (CRA) will identify, select, initiate and close out appropriate investigational sites for Clinical Studies. The successful candidate will monitor these sites in order to ensure compliance to the study protocol, Standard Operating Procedures, applicable regulations and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with the relevant SOPs and regulatory requirements and study completion on time and within budget.

 The Role:

 Ensuring the management of trials is done in compliance with ICH, GCP, Company/Sponsor global standards, local laws and regulations.

  • Ensuring clinical trials are effectively executed and completed within budget, timelines and meeting enrolment commitments as well as routine updating of CTMS and other clinical systems. Pro-active trial management to identify challenges, develop effective mitigation plans and to appropriately escalate and inform all relevant parties.
  • Manage site pre-selection and validation process.
  • Support local investigator meetings, ensure contracts and applicable regulatory documentation is obtained prior to study start, facilitation of all aspects of IRB/ERC review and HA approvals as needed.
  • Act as main point of contact for all logistical and operational issues and facilitate general communication.
  • Oversee drug and clinical supplies management to ensure sites have timely availability of required materials to avoid disruption of protocol deliverables and to oversee appropriate final disposition of IMP.
  • Ensure clinical study site close-out in accordance with local regulations and ensure dissemination of clinical trial results to the participating study investigators.
  •  Oversee appropriate file archiving of all relevant study materials in accordance with local law and Company/Sponsor guidelines.

Experience/Qualifications required

Skills:

 Clear understanding of the drug development process

  • Should be able to identify problems and escalate to management as appropriate: Specific examples of common problems include: 1) low patient recruitment, 2) inadequate sponsor staff to meet business needs, 3) compliance issues and study quality, 4) working with regulatory issues and broader organisation, 5) Identify and mitigate FA deliverables that will hinder meeting milestones
  • Should have strong organisation and team leadership skills and ability to focus on multiple deliverables and sites simultaneously
  • Able to build professional relationships with a wide range of people including investigators, internal employees
  • Contribute to development of country specific trial and site budgets
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail

 Language Skills:

  • Fluency in English language (both written and spoken)
  • Fluency in French and Dutch (both written and spoken)

 Attributes:

  • Willingness and ability to travel up to 60% of the time
  • Willingness and ability to be based in office based Brussels, Belgium
  • Must be permitted to work the EU

 Experience:

 Significant experience in performing a Clinical Research Associate role

  • Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or pharmaceutical company
  • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials

 Qualifications:

 Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline

Clinical Research Associate

Reference number: 1955 Apply for this job Apply for this job »
Type: Permanent, full time Location: Midlands and the South East, UK

Job Description

Summary:

 Responsible for monitoring our client’s clinical trials to ensure that investigators are conducting the research within requirements of the clinical protocol, that research is conducted in accordance with applicable federal regulations / EU Directive and guidelines, that data quality on initial review meets acceptable clinical standards, and the rights and safety of human subjects involved in a clinical study are protected.

 Reports to CRA Manger, Clinical Monitoring.

 The Role:

 ·         Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.

·         Coordinates activities with the site in preparation for the initiation of studies. Works with the Study Start-up group to obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.

·         Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities.

·         Trains site staff on the EDC system and assists in verifying site computer system.

·         Conducts periodic site file audits to ensure compliance with GCPs and our client’s standard operating procedures.

·         Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor.

·         Prepares monitoring reports and letters using approved (by our client or the sponsor) forms and reports whilst adhering to study specific timelines.

·         Documents accountability, stability and storage conditions of clinical trial materials as required by the sponsor. Performs investigational product inventory.  Ensures return of unused materials to designated location or verifies destruction as required.

·         Performs study close out visits.

·         Reviews the quality and integrity of the patient clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

·         Serves as primary contact between our client and the investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

·         Assists with, and attends, Investigator Meetings for assigned studies.

·         Actively participates in study specific team calls on a weekly basis

·         Assists with final data review and query resolution through database lock.

·         Authorised to request site audits for reasons of validity.

Experience/Qualifications required

Skills and Attributes:

 ·         Knowledge of clinical research process and medical terminology.

·         Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

·         Good organisational and interpersonal skills.

·         Ability to reason independently and recommend specific solutions in clinical settings.

·         Understand electronic data capture including basic data processing functions.

·         Understand current GCP/ICH guidelines applicable to the conduct of clinical research.

·         Able to qualify for a major credit card.

·         Valid driver’s licence; ability to rent automobile.

·         Willingness and ability to travel domestically, as required, 50% to 75% of the time.

·         Computer literacy and knowledge of electronic data capture preferred. 

·         Must possess good written and verbal communication, interpersonal, and organisational skills. 

 Experience:

 ·         Six to twelve months experience in monitoring and/or coordinating clinical trials required; experience in an oncology clinical trial setting a plus.

 Qualifications:

 ·         BSc/BA in one of the life sciences with a minimum of 6-12 months of field monitoring experience or equivalent amount of education/experience.

Senior Clinical Research Scientist

Reference number: 1939 Apply for this job Apply for this job »
Type: Permanent, full time Location: Hampshire

Job Description

Summary:

 This function will lead the study team to design, develop and deliver the clinical study. Authorship of protocols, ICFs and study related plans.

 The Role:

 Responsible for the clinical review and approval of Case Report Forms and provides clinical input into corresponding completion guidelines.

 Oversees the management of CRO activities and other clinical vendors to ensure the robustness of their systems and that quality is consistent.  Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.

 

The Senior Clinical Research Scientist will be responsible for the execution and management of global clinical studies in CNS and will have previous experience in a CRO or Pharmaceutical company at a similar level. He/she will manage clinical outsourcing activities and will be the author of protocols, informed consent forms and study related plans.

 

Experience/Qualifications required

Experience:

 Must have CNS experience / background. (Psychiatry - Alzheimer, Parkinson, Depression, Schizophrenia).

 Previous vendor management experience and management of multi-centred global (Phase II-IV) clinical trials is required.

 Must have EU experience ie. not just UK experience.

 APAC experience desirable.

Data Management

Last updated: 09:57 05/03/2013

Senior Data Manager

Reference number: 2003 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based in Ely, UK

Job Description

Salary and Benefits:                       £36k to £38k

 Benefits are after 6 months probation period:   Company pension scheme (company 5% employee 3%), Private Medical Insurance, Life Assurance, Medical Benefit scheme. 

 A Childcare Voucher scheme is also in operation.

 

Summary:

 This is an operational data management role involving the handling of data inconsistencies and activities through to the locking of the database.  The Data Manager will be responsible for performing all relevant data management activities during the maintenance and closure phases of a study.  This senior role will also include department process overview and training / mentoring of staff within the department.

  The Role:

 ·         To process clinical data for allocated projects.

·         To critically review CRFs as specified in the Data Management Plan and to query any errors or omissions with either the study sponsor or the investigator as appropriate.

·         To code adverse events, medical history and medications.

·         To raise, track queries, and manage the query process for responsible studies.

·         To complete all data management activities to deliver clean and high quality controlled databases to schedule.

·         To report progress against schedules to management as appropriate.

·         To be aware of and to work to the standards appropriate to the study (CRO or sponsor).

·         To carry out systems validation work as requested.

·         To perform the QC procedures on project/study related documentation.

·         To fulfil job responsibilities in accordance with Good Clinical Practices (GCP), Company Standard Operating Procedures (SOPs), Study Specific Procedures (SSPs), and all applicable laws and regulations.

·         Mentoring and training of DM staff

·         Process review and improvement

·         Department point of contact

·         Assessment of project resource

·         Assist with project budget

·         Business development support including costings and client liaison

·         To perform other reasonable tasks as requested by management.

Experience/Qualifications required

Skills and Attributes:

 ·         Understanding of data management and regulatory requirements.

·         PC skills including data management software; appreciation of medical terminology and clinical practice.

·         Excellent accuracy and attentiveness to detail.

·         Excellent written and oral communication skills.

·         Good organisational skills and interpersonal skills.

·         Ability to work alone or within a team environment.

·         Ability to manage competing priorities in a changeable environment.

·         Ability to handle work to tight deadlines.

 Experience:

 ·         Preferably at least 4 years (or equivalent competency) experience in data management, within the pharmaceutical industry.

 Qualifications:

 ·         Qualified to an appropriate standard, preferably to degree level in a life sciences subject.

 

Senior Clinical Data Manager

Reference number: 1997 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex Office or home based

Job Description

Summary:

 Carry out the required data management tasks within the clinical trial environment. Take a lead role on assigned studies with responsibility for set-up, conduct and locking the database to high quality and in accordance with our client’s contractual obligations and Standard Operating Procedures .

 The Role:

 ·         Review and understand clinical trial documentation and, if appropriate, contribute to the preparation of documents such as the protocol.

·         Prepare and review trial level documentation such as CRF completion guidelines, Data Management Plan, validation check specifications, User Acceptance Testing (UAT) plans, reports and conventions necessary to ensure high quality and consistent data.

·         Set up and maintain accurate trial documentation and filing systems to ensure safe and secure storage of data and documentation.

·         Provide input into eCRF/CRFs, clinical trial database design and validation check programming.

·         Perform User Acceptance Testing of assigned clinical trial databases.  Resolve any errors with the relevant programmer.

·         Create listing specifications to be programmed or create basic reports using available software.  Review data listings as part of the data review process.

·         Take a lead role and act as the main Sponsor contact for CDM activities on assigned trials. Ensure ongoing data processing (data entry, cleaning, quality checking, Coding, Serious Adverse Event reconciliation) and highlight any issues that may affect data quality. Identify errors or inconsistencies and resolve them or initiate their resolution, using the Sponsor’s preferred approach.

·       Ensure the implementation of the guidelines across the trial and that they are consistently adhered to.

·       Ensure all relevant individuals, e.g. Senior Management and /or Sponsor are regularly updated on project status.

·       Proactive planning and forecasting of workload requirements 

·       Load any required electronic data into the trial database at designated time points throughout the trial, and liaise with the data vendor and/or investigator site to resolve any resulting errors.

·       Maintain an accurate status of all aspects of the trial, e.g. data entered, cleaned and be proactive in ensuring smooth and successful timely locking of databases.

·       Ensure tasks documented in the study contract are completed on time and have an understanding of the trial budget.

·       Identify and manage changes in scope.

·       Adhere to relevant Sponsor and / or company CRS Standard Operating Procedures and policies.

·         Provide Clinical Investigational Trial Site/Sponsor staff study specific training for EDC trials and provide ongoing support to site.

  • Run assigned Technical Training Module (TTM) training and assess the competency of participants, if required.

·         Respond to requests made by the Sponsor for information or presentations such as workshops and project planning meetings as appropriate.

·         Prepare for and participate in internal and external audits.

·         Communicate effectively with the Sponsor via e-mail, telephone conferences, presentations etc in order to fully manage and lead the project or trial.

·         Train, coach and mentor Clinical Data Associates II and Clinical Data Managers. Conduct departmental training workshops or presentations as required.

·         Participate in and support Business Development activities, e.g. bid defence meetings etc.

·         Actively promote and represent the company via attendance at meetings and conferences and, as appropriate, become a member/involved with professional associations.

·         Contribute to departmental processes and technical improvement efforts.

·         Assist and act as deputy for the Principal Clinical Data Manager or Manager, Clinical Data Management as appropriate.

·         Ensure timely and accurate entry of study information in the time recording system

·         Performs other tasks as assigned by line manager.

Experience/Qualifications required

Skills and Attributes:

 ·         Proficient planning, prioritisation and organisational skills and an understanding of resource and budgeting

·         Very good interpersonal and communication skills and the ability to operate effectively in a global working environment

·         Ability to perform the role of a Data Management functional lead, from database setup to lock, efficiently and to a high standard

·         Team player with an ability to build good relationship with Sponsors and manage their needs and expectations

·         Work calmly under pressure and meet deadlines

·         Professional, positive, dynamic and driven

·         Thorough understanding of medical terminology, clinical trial methodology and ICH/GCP

·         Thorough level of understanding of physiology, pharmacology, clinical study objectives and the drug development process

·         A very good investigative and meticulous approach to all activities and tasks

·         Good negotiation and problem solving skills

·         Transparent approach, clear and precise

·         Demonstrate leadership and accountability skills such as  the ability to coordinate teams and delegate tasks to meet deadlines 

·         The ability to work effectively and efficiently as part of a study team

·         Eagerness to learn and develop new skills

 Experience:

 ·         Typically 4 or more years experience in drug development, at least 2/3 years in the discipline of data management and 1-2 years leading project teams.

 
 Qualifications:

 Degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience.

  • Foreign language skills would be advantageous.

Senior Data Manager

Reference number: 1994 Apply for this job Apply for this job »
Type: Permanent, full time Location: Stirling Scotland, Office based

Job Description

Summary:

 Our client is an international, full-service Contract Research Organisation. For more than 14 years it has provided ISO certified clinical development services to the pharmaceutical, biotechnology, vaccine and medical device industries for products and devices in a broad range of therapeutic areas.

The Role:

  • Perform data management project duties (project set-up, project planning, project review and reporting, project coordination and mentoring) as required by the project manager, to ensure appropriate quality of data management deliverables within agreed timelines and with control over the available budget
  • Fulfil responsibility for all in-house data management processes, including in-house review, data coding, data entry, discrepancy management, data validation in clinical trials to ensure appropriate quality of data management deliverables within agreed timelines
  • Write or review the Data Management specific study documents (e.g. Data Management Plan, Data Validation Plan, Data Handling Specifications for 3rd party vendors providing external data) to describe and define data management activities and procedures that must be followed in order to meet the requirements of the study
  • Program or supervise the set-up of the clinical trial database and the adjacent data validation routines within the clinical data management system (CDMS)
  • Program data listings and complex validation checks in SAS and/or PL/SQL
  • Perform project related communication with all internal and external parties
  • Perform consultancy for clients with respect to Data Management processes to allow for smooth conduct of the project
  • Liaise with internal business units as needed in the study conduct
  • Perform data management training or presentations for internal/external clients ensuring their high scientific level
  • Attend (blind) Data Review Meetings in order to provide professional support in data management related matters
  • Attend bid defence meetings with clients to provide professional support in Data Management related matters
  • Plan and conduct client meetings as required in the project content

Experience/Qualifications required

Skills and Attributes:

 Excellent knowledge of data management and the relevant knowledge of guidelines for the conduct of clinical trials and medical investigations (e.g. ICH-GCP, EN ISO 14155)

  • Good knowledge in the conduct of EDC trials preferably with Oracle Clinical RDC
  • Fluent in English written and verbal communication
  • Expert in the usage of a Clinical Data Management System, preferably Oracle Clinical
  • Good programming knowledge of SAS and SQL

 

Experience:

 

  • At least five years of practical experience in data management within the conduct of all stages of a clinical trial

 

Qualifications:

 

  • Higher education in sciences, medical or paramedical sciences, medical information specialist or other equivalent scientific training

Senior Clinical Database Programmer

Reference number: 1941 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Berlin

Job Description

The Senior Clinical Database Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies. In addition, the Senior Clinical Database Programmer can fill the Database Primary role on projects, and liaise with sponsors, Data Operations Leader, and other functional areas as required.

There are two specific functions that may be filled by the Senior Clinical Database Programmer, dependent on skill sets and experience:

Clinical Systems and Support Programmer and Database Programmer.

 Relationships

Reports to Manager, or above

Directly Supervises N/A

Provides work direction to Clinical Database Programmer I & II, Technical Analysts, other members of the GRO department as appropriate.

Works closely with Technical Analysts and Statistical Programmers, Data Processing,

Biostatistics, Data Operations Leaders, QMG, RRC, Medical Writing, IT, Proposals and Business Development.

External Relationships:  Sponsors, Third Party Vendors, Auditors

Experience/Qualifications required

 Database Programmer

• Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.

• Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in applicable CDMS and EDC, following and understanding internal and external regulatory requirements.

• Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.

• Perform medium size to complex ad-hoc programming tasks.

• Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).

 Skills:

• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).

• Knowledge of the programming and reporting process within GRO.

• Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

• Demonstrate ability to learn new systems and function in an evolving technical environment.

• Strong leadership ability.

• Attention to detail.

• Ability to work together with a team (including international teams as required) as well as independently.

• Demonstrate strong organisational skills, ability to manage competing priorities, and be flexible to change.

• Business/Operational skills that include customer focus, commitment to quality management and problem solving.

• Good business awareness/business development skills (including financial awareness).

• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.

• Work effectively in a quality-focused environment.

• Demonstrate commitment to refine quality processes.

Language skills:

• Excellent English written and oral communication skills.

 Experience:

 • Relevant Clinical Trial industry experience

• Experience working with at least one system used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting)

 Qualifications:

 • First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.

Clinical Database Programmer II

Reference number: 1940 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Berlin

Job Description

Summary:

 The Clinical Database Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to clinical systems and/or the applications/systems within eClinical technologies. There are two specific functions that

may be filled by the Clinical Database Programmer II, dependent on skill sets and experience:

Clinical Systems and Support Programmer and Database Programmer.

 

 The Role:

Reports to Manager, or above

Directly Supervises N/A

Provides work direction to Clinical Database Programmer I, Technical Analysts, other members of the GRO department as appropriate

Works closely with Technical Analysts and Statistical Programmers, Data Processing,

Data Operations Leaders, Biostatistics, QMG, RRC, Medical Writing, External Relationships Sponsors, Third Party Vendors, Auditors

Clinical Systems and Support Programmer

• Coordinate and execute system specific project start-up activities.

• Configure and implement eClinical applications/systems specifically required in a project including, but not limited, to Medical Safety Reporting (ISIS), ARGUS, CTMS (IMPACT), PMED.

• Execute ongoing maintenance tasks, performance evaluations and tuning of eClinical

applications/systems

• Provide optimum monitoring, support, and maintenance of a reliable, quality, integrated eClinical application/system environment.

• Set up / configure automatic reports for studies within the eClinical applications/systems.

• Execute automatic import and export of data.

Database Programmer

• Create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.

• Create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.

• Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.

• Perform small to medium size ad-hoc programming tasks.

 

Experience/Qualifications required

Skills:

• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).

• Knowledge of the programming and reporting process within GRO.

• Knowledge of SOPs/Guidelines/WorkInstructions/ System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

• Demonstrate ability to learn new systems and function in an evolving technical environment.

• Attention to detail.

• Ability to work together with a team (including international teams as required) as well as independently.

• Demonstrate strong organisational skills, ability to manage competing priorities, and be flexible to change.

• Business/Operational skills that include customer focus, commitment to quality management and problem solving.

• Work effectively in a quality-focused environment.

 Language Skills

• Very good English written and oral communication skills.

 Experience:

 • Relevant Clinical Trial industry experience

• Experience working with at least one system used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting)

 Qualifications:

 First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.

Senior Data Manager

Reference number: 1924 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Central London

Job Description

Job Description:

We are assisting our client, a charity based in Central London, in finding a Senior Data Manager. This is a six month fixed term contract with the likelihood of becoming permanent.

 Purpose of Job

The Senior Data Manager is responsible for ensuring that all data management and statistical activities are conducted in accordance with the clinical trials legislation and guidelines. The Senior Data Manager will manage, co-ordinate, oversee and deliver all data management and statistical activities and provide leadership and management of personnel associated with these activities

 Major responsibilities

 Managing the Biometrics Team

•           To act as the primary contact for data management, statistics, monitoring and regulatory personnel (the Team) in terms of Biometrics

•           To provide effective leadership in ensuring standards and policies are adhered to and are compliant with GCP

•           Working with the Team to ensure each member understands their role

•           To encourage active collaboration and open communication with wider multidisciplinary team members within the company.

•           Planning and management of day-to-day workloads within the team to ensure adequate project resource in order to achieve timelines.

•           Ensuring processes and procedures are compliant with the Data Protection Act and team members understand their responsibilities with regard to the Act.

 Managing Outsourced tasks

•           Primary point of contact for the project team including the outsourcing service provider.

•           Provide and receive essential study documentation and ensures all required documentation is in place at the correct time.

•           Full awareness and understanding of the scope of studies to ensure all deliverables are met, all changes in scope of the work are identified and highlighted at the earliest opportunity with regard to the impact on resource and/or budgets.

 Coordination and Communication

•           Communication with the Principal Investigator throughout the trial so that expectations are met in terms of timelines and study deliverables 

•           Coordination of processes and activities across the functions to ensure processes are complete and without duplication.

•           Compilation and maintenance of regular status reports of Biometric team activities, resource and training issues, ensuring information is provided to the Management

•           Analysis of issues and the use of judgment to make decisions/suggestions for resolution of issues.

•           Application of knowledge of company policies and standard practices to advise on processes and resolve problems.

•           Effective escalation to the appropriate person for non-standard problems or issues as required.

 Implementation/review of Systems and Procedures

•           Overseeing development and maintenance of data management and statistics  SOPs

•           Ensuring availability and suitability of the appropriate tools for data collection.

•           Playing a lead role in development of study documents including protocols, CRFs, analysis plans and other Biometrics documentation.

 Training and Support

•           Provision of guidance, support and on-the-job practical training to the Data Manager and study statistician(s)

•           Development of Competency Checklists for the biometrics team to ensure the correct level of competency necessary to perform the job

•           Development and coaching of team members including regular, ongoing review and assessment of individual’s competencies and provision of feedback to their line manager.

•           Input into training records for Biometric team members.

•           Identification of individual training needs for the Data Manager and Statistician.

•           Sourcing of essential training material.

•           Provision of support and training for other functional groups within the company as required.

 Ensure the consistent delivery of quality clinical trial data within required timeframes

•           Review and input into protocols to ensure that data is handled efficiently, consistently and in accordance with GCP

•           Development, monitoring and improvement of procedures and tools for data collection, ensuring efficiency and completeness of all biometrics processes

•           Review and approval of Biometrics related documentation e.g. the Biometrics Plan, Data Handling documents, QC Plan

•           Overseeing appropriate restricted access for study databases by liaison with the C&W IT department as required.

•           Validating individual study database design and working with the Data Manager to resolve issues encountered during validation

•           Validating the import and export of external data such as lab data into the database

•           Ensuring accuracy of the data entered onto the clinical database by performing a Quality Control review of the data

•           Ensuring that data queries are raised, tracked and resolved appropriately

•           Overseeing appropriate quality control for statistical systems e.g. validation of the analysis programming, transfer of data into statistical packages and quality control checks of statistical output

•           Overseeing data base reconciliation e.g. in case of separate safety and clinical databases

•           Ensuring review of protocol / GCP deviations in terms of impact on the analysis and assignment to analysis populations

•           Ensuring that the data management file is up to date and maintained

•           Ensuring that all study related documents and the study database are archived according to company procedures and within agreed timelines

 Other responsibilities

•           Taking a lead role in external and internal Biometrics audits

•           Other tasks as required in order to meet the changing needs of the organisation

•           Budget generation and notification of out of scope activities

Experience/Qualifications required

Candidate Requirements:

Experience

•           A Life Science (BSc) or Nursing degree (or equivalent)

•           Relevant Clinical Research experience

•           Project management experience

•           Line management experience (preferable)

•           Technical expertise with clinical trial software and databases

•           Familiarity and a good understanding of statistical analysis and programming

 

Essential knowledge/skills

•           Broad knowledge and cross-functional understanding of clinical trial methodology.

•           Knowledge of UK Clinical trial Regulations (SI 2004/1031 as amended)

•           Knowledge of clinical drug development process in biotechnology or pharmaceutical industry

•           Excellent written and verbal communication skills

•           High level of interpersonal skills, a good team player

•           Proactive

•           Motivated and enthusiastic

Database Programmer II

Reference number: 1920 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sussex

Job Description

Job Description:

We are assisting our client a highly respected specialist Data Management CRO in looking for a Database Programmer II for their offices in Sussex.

 They are looking for an enthusiastic individual to configure their proprietary databases – screen design, visit definition and validation programming – to tight specifications and deadlines.

 The job also involves programming third-party loaders (in Python), testing validation checks, maintaining a range of professional interfaces and representing the department.

Experience/Qualifications required

Candidate Requirements:

Relevant computer science and database programming qualifications are required, as well as some experience of clinical database applications and knowledge of EDM and EDC processes.

 The ability to work under pressure and as part of a team is also important in this role. Foreign languages would be an advantage.

 This is a permanent position.

IT

Last updated: 10:33 05/03/2013

Senior PHP Developer

Reference number: 2006 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based in Ely, UK

Job Description

Salary and Benefits:                       £36k to £40k

 Benefits are after 6 months probation period:   Company pension scheme (company 5% employee 3%), Private Medical Insurance, Life Assurance, Medical Benefit scheme. 

 A Childcare Voucher scheme is also in operation. 

 Summary:

 This is an operational senior web developer role involving designing, coding and testing solutions to technical problems.

 This is an excellent opportunity for a PHP Developer with MySQL experience to join the company’s team of developers working on its web based analysis tools.

 Within this challenging and technical environment the successful candidate will be responsible for the design and build of new systems using PHP, MySQL, JavaScript and XML, as well as the ongoing development and maintenance of the company’s existing systems.

 The Role:

 ·         Liaise directly with clients to establish user requirements

·         Create project plans and user requirement specifications

·         Manage the project team to ensure timelines are adhered to and effectively reprt any potential problems with project requirements and deadlines

·         Design, coding and testing of technical solutions

·         Understand standard system development lifecycle processes and applies our methodology effectively on client engagements.

·         Apply and share knowledge of industry trends and developments to improve service to clients.

·         Understand project and development plans and is able to clearly articulate roles, project goals, and timelines

·         Adhere to coding standards defined by technical management.

·         Establish responsible deadlines and personal work plans.

·         Mentor junior developers

 The role will include:

- Ongoing development and maintenance

- Writing technical specifications to help develop new functionality

- Building creative and reliable solutions within this multi-tier application environment

- Providing timely solutions to software issues whenever they are identified

Experience/Qualifications required

Skills and Attributes:

·         Good communications and client management skills

·         Understands basic relational database concepts

·         Confident in SQL.

·         Possesses knowledge of various database access methods.

·         Possesses detailed knowledge of PHP5.

·         Exhibits proficiency in MySQL, HTML, CSS, XML/XSL and JavaScript.

·         Basic knowledge of Apache.

·         Demonstrates basic knowledge of object and component methodology and technology.

·         Possesses basic knowledge of classes, components, objects, and interfaces.

·         Requirements gathering and systems design

·         Recognises the fundamental differences between the various internet browsers.

·         Demonstrates flexibility in day-to-day work.

·         Ability to work alone as well as part of a team.

·         Ability to prioritise work load.

 Experience:

 ·         3+ years experience in web based software development.

 Qualifications:

 ·         Preferably qualified to diploma level in a software development discipline.

PHP Developer

Reference number: 2005 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based in Ely, UK

Job Description

Salary and Benefits:                       £30k to £35k

 Benefits are after 6 months probation period:   Company pension scheme (company 5% employee 3%), Private Medical Insurance, Life Assurance, Medical Benefit scheme. 

 A Childcare Voucher scheme is also in operation. 

 Summary:

 This is an operational web developer role involving designing, coding and testing solutions to technical problems.

 This is an excellent opportunity for a PHP Developer with MySQL experience to join the company’s team of developers working on its web based analysis tools.

 Within this challenging and technical environment the successful candidate will be responsible for the design and build of new systems using PHP, MySQL, JavaScript and XML, as well as the ongoing development and maintenance of the company’s existing systems.

 The Role:

·         Design, coding, and testing of technical solutions.

·         Understand standard system development lifecycle processes and applies the company’s methodology effectively on client engagements.

·         Apply and share knowledge of industry trends and developments to improve service to clients.

·         Understand project and development plans and is able to clearly articulate roles, project goals, and timelines

·         Adhere to coding standards defined by technical management.

·         Establish responsible deadlines and personal work plans.

·         Mentor junior developers

The role will include:

- Ongoing development and maintenance

- Writing technical specifications to help develop new functionality

- Building creative and reliable solutions within this multi-tier application environment

- Providing timely solutions to software issues whenever they are identified

Experience/Qualifications required

Skills and Attributes:

·         Understands basic relational database concepts.

·         Confident in SQL.

·         Possesses knowledge of various database access methods.

·         Possesses detailed knowledge of PHP5.

·         Exhibits proficiency in MySQL, HTML, CSS, XML/XSL and JavaScript.

·         Basic knowledge of Apache.

·         Demonstrates basic knowledge of object and component methodology and technology.

·         Possesses basic knowledge of classes, components, objects, and interfaces.

·         Requirements gathering and systems design

·         Recognises the fundamental differences between the various internet browsers.

·         Demonstrates flexibility in day-to-day work.

·         Ability to work alone as well as part of a team.

·         Ability to prioritise work load.

 

Experience:

 

·         2+ years experience in web based software development.

 

Qualifications:

 

·         Preferably qualified to diploma level in a software development discipline.

 

Software Engineer

Reference number: 1975 Apply for this job Apply for this job »
Type: Permanent, full time Location: Croydon UK

Job Description

Summary:                

 Our client is a specialist in the field of neonatal ventilation.

 The main function of the job is to work within the design and development team responsible for developing, implementing, testing, supporting, and maintaining software builds for the development of the next generation of our client’s products.

The successful candidate is likely to have a BSc or MSc in Engineering in one of the following disciplines - Mechanical, Chemical, Aerospace, Composite Automation, and Computer Science.  Essential is excellent programming experience in C, C++ and WinCE and object oriented design, preferably from an aviation or automobile industry.  Ideally s/he will have electronics experience.  First class analytical, communication and time management skills and a high standard of technical documentation is essential.

 

The Role:

 1.The coordination of all software product lifecycle activities leading to successful project implementation

2.Design of embedded software using appropriate methodologies

3.Review and interpretation of product specifications

4.Preparation of technical specifications, test plans and operational documentation

5.Software configuration management and version control

6.To maintain a high level of communication with the hardware engineers related to current projects and product design

Experience/Qualifications required

1.Excellent programming experience in C, C++ and WinCE, object oriented design, preferably from an aviation or automobile industry.

- Low level device drivers under Windows CE experience.

- 8051 familiarity.

- CAN bus familiarity.

- Comms Protocols/Networking depending on our plans (egg USB).

2.Experience in developing desktop applications, with good appreciation of embedded solutions in a real-time environment.

 3.Risk Analysis, safety critical systems, design documentation and general software lifecycle with experience in developing safety critical software is essential.

With knowledge of IEC60601 or equivalent safety critical standard is desirable

 4.Engineering project management experience

5.Software verification and validation (egg software test handlers, integration tests)

6.Familiarity with Microchip PIC microcontrollers

7.High standard of technical documentation

8.Excellent analytical, communication and time management skills

9.Hardware

 - Construction and Testing/debugging of mechanical/electrical prototypes.

- Pneumatics design.

- Hardware digital/analogue design

- Experience in HDL advantages

   Qualifications:

 BSc, MSc in Engineering - Mechanical, Chemical, Aerospace, Composite

Automation, Computer Science, Electronics experience

Training Manager

Reference number: 1968 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex

Job Description

Summary:

 To create and deliver training in our client’s EDC system to end users, through the most appropriate methodology.  Ensure continual improvement of training.

 The Role:

 Plan, design and deliver our client’s EDC system training/interventions to meet customer needs as defined within the relevant contract.

  • Serve as a training adviser and consultant for Technology.
  • Liaise with internal and external customers to clarify training needs, review materials, advise on updates and agree solutions.
  • Develop, prepare and maintain training materials to ensure a consistent global approach.
  • Evaluate training delivery and other training interventions on an ongoing basis
  • Apply the principle of continuous improvement to the training function, approach and materials.
  • Maintain up to date knowledge of training techniques and methodologies.
  • Provide full training support to trainees.
    • Management of training rooms and facilities, when onsite at our client’s premises
    • Trainer and delegate correspondence,
    • Training related documentation and other materials,
    • Maintenance of individual training calendar.
  • Act as point of contact for the Training department in the absence of line manager.
  • Adhere to relevant SOPs, oversee maintenance of training database.
  • Other tasks as deemed appropriate by line management

Experience/Qualifications required

Experience:

 ·         At least 5 years’ experience in a technical training environment

·         Experience of electronic data capture platforms and/or clinical trials process

·         Experience of training within a regulated environment.

  Qualifications:

 ·         Recognised degree in science or technology

Senior EDC Trial Builder

Reference number: 1962 Apply for this job Apply for this job »
Type: Permanent, full time Location: Amsterdam

Job Description

Summary:

 Develop and program EDC trial databases for global clinical trials, Phases I to IV, by setting up eCRFs and programming associated edit checks and variable mappings for data extraction based on specifications provided by the Clinical Data Coordinators. Program trial specific and ad-hoc reports within the EDC system. Perform thorough development testing (point-to-point) and deliver EDC trial packages and reports that are ready for User Acceptance Testing. Prepare and maintain validation documentation related to the trial and report development phase, review user requirement and provide input on technical aspects.

 This position reports to the EDC Trial Builder Manager or Head or EDC.

  The Role:

 Develop EDC trial databases for several protocols and projects. In particular:

  • Develop eCRFs according to user specifications
  • Program EDC edit checks according to user specifications
  • Program reports within the EDC system according to user specifications
  • Perform and document point-to-point developer testing
  • Deliver EDC trials databases and reports that are ready for User Acceptance Testing
  • Implement updates to eCRFs, edit checks, reports of ongoing trials according to user specifications
  • Complete activities within the time frame of established metrics
  • Adhere to SOPs and guidelines
  • Identify problems, analyse them, and suggest solutions
  • Support development and maintenance of Standard eCRFs, edit checks, variable mappings and reports
  • Assist in authoring, and participate in the review of procedures and guidelines related to EDC programming
  • Perform other duties as assigned

 Performance Indicators:

 Timely and high quality completion of EDC trials, including eCRF, edit checks, variable mappings, and reports for assigned trials. Timely and high quality documentation of trial development. Contribution to innovation and continuous improvement of systems, procedures, working practices, and standards.

 Impact on the Client Organisation:

 Timing and quality of EDC databases directly affect submissions to regulatory authorities. Responses to health authorities directly affect regulatory submissions. Contribute to innovation and continuous improvement of systems, procedures and standards.

Experience/Qualifications required

Language Skills:

 English, excellent spoken and written.

Skills and Experience:

 Typically, 2 years or more of experience in clinical programming, set-up of clinical databases and CRF design, gained in the pharmaceutical industry or in CROs as well as the following:

  • EDC builder software, preferably InForm with Central Designer or Architect, strong knowledge of database support: Oracle (SQL or PL/SQL) and equivalent clinical database management system
  • Strong knowledge of CDISK/CDASH
  • Strong knowledge in reporting support: Cognos, SQL, SAS or other ad-hoc query and reporting tools

·         Strong understanding of clinical database management systems and/or relational databases as applied to clinical trials

·         Ability to analyse the impact of complex changes to clinical standards, with minimal supervision

·         Ability to multi-task with minimal supervision

·         Ability to switch between different tools for database design and management

·         Strong understanding of ICH and Health Authority guidelines and regulations as they pertain to clinical database management and computer systems.

·         Strong attention to all of the following: detail, quality and customer focus.

·         Ability to work to deadlines independently.

·         Strong communication skills required in order to be able to work with a wide variety of customers both face-to-face and via phone or e-mail.

·         Candidates with experience in eCRF design - independent of the system used - are preferred.

 Qualifications:

 A Bachelor’s or Master’s degree or equivalent, preferably in Computer Science, Life Science, or Engineering.

Management

Last updated: 11:36 22/02/2013

Contracts and Proposals Manager

Reference number: 1998 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex, Office based

Job Description

Summary:

 ·         Prepare contracts, proposals and contract amendments.  Responsibilities include proposal and change order preparation, payments schedule generation and cash flow analysis, task orders creation, internal budget and client grid completion.  

·         Provide accurate and timely tracking and reporting of contract and proposal data.

·         Submit deliverables accurately and timely.

 The Role:

 Work with Subject Matter Experts (“SMEs”) in CRO Operations, Technology and Business Operations to prepare documentation for secrecy agreement, proposals, contracts and change orders.

  • Manage the proposal or change order process, setting timelines for completion including critical path interim milestones and accountabilities, and contingencies in the event those milestones are not achieved. Proactively escalate issues and /or propose solutions in order to meet target delivery dates.
  • Use technical and creative writing skills to ensure documentation clearly articulates the company’s attributes, service offerings, and contractual limitations.
  • Use commercial, fiscal and budgetary skills to develop budgets that match the service offering included in the proposal or change order.  Includes ensuring contained costs are accurate and justifiable, and include the appropriate inflation, hourly rates and currency exchange.
  • Create or review payment schedules and terms to ensure cash neutrality and conformance with company standards.
  • Quality check deliverable prior to submission to clients.
  • Provide ad-hoc analysis as requested to assist the company management.
  • Lead special projects to improve the quality of the company’s proposals or change orders.  Sample project may include managing the company proposal module library in conjunction with SMEs, creating or maintaining pricing systems, or maintenance and reporting of standard departmental metrics or reports through corporate CRM application.

 Note : The above job description in no way states or implies these duties are the only duties performed by this employee.  The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

 

 

 

Experience/Qualifications required

Skills and Attributes:

 Outstanding business, technical and sales-oriented writing skills - ability to convincingly and articulately convey technical and/or operational expertise, services, and attributes.

  • Experience developing or analysing pricing in the CRO, Pharmaceutical or Software industries.
  • Ability to prioritise and manage numerous short-term projects quickly, accurately, and efficiently in a fast paced environment and under intense deadline pressure.
  • Ability to advise and interact with all levels of management.
  • Demonstrated commercial, fiscal, analytical and mathematical skills.
  • Strong Outlook, Word, Excel and MS Office skills.
  • Superior organisational skills.
  • Excellent communication and interpersonal skills.

·         Strong leadership skills.

·         Diligence, flexibility, attention to detail.

 Experience:

  • Two (2) years’ experience in a CRO, pharma/biotech outsourcing or software company in a similar role.

 Qualifications:

 Bachelor's Degree in a business field, or a life sciences degree with equivalent work experience

Global Studies Manager

Reference number: 1963 Apply for this job Apply for this job »
Type: Permanent, full time Location: Welwyn Garden City, UK

Job Description

Main Responsibilities and Accountabilities:

 Provides direction and leadership to one or more clinical operations teams

• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.

• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.

• Creates team culture and promotes team spirit.

• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.

• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.

• Oversees the development and maintenance of study specific manuals created by the GSA.

Contributes to the development and management of the study timelines, resources, budget, risk and quality plans

• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.

• Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.  Communicates variances in the budget and action plan for resolution to the GSL.

• Establishes study milestones and ensures accurate tracking and reporting of study metrics. 

• Provides operational input into the development of protocol feasibility questionnaires. 

Provides clinical operations expertise to ensure operational feasibility and delivery

• Leads the development and finalization of site feasibility questionnaires.

• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.

• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.

• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.

Oversees forecasting of clinical/non-clinical supplies

• Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.

• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.

Delivers the operational elements of the study plan

• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.

• Ensures that reporting of SUSARs is established and maintained for the duration of the study.

• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.

• Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.

• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.

• Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.

• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.

• Provides operational input into the development and tracking of SMT goals.

 •  Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work

• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.

• Develops and executes appropriate site and CRO/vendor audit and quality plans.

 • Identifies areas of best practice and process improvements

• Participates in Pharma Development Operations initiatives and programs as assigned.

• Maintains oversight and ensures consistency of the operational aspects across studies within a project.

Ensures study adherence to ICH/GCP and SOPs

Experience/Qualifications required

Qualifications:

Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.

Skills & Knowledge:

 Experience

·          Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.

·          Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.

·          Good knowledge of ICH GCP

·          Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.

·          Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.

·          Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.

 

Competencies

•      Project Management

•      Collaboration and Teamwork

•      Negotiating

•      Communication

•      Personal Organization

Business Development Manager/Director - Technology

Reference number: 1961 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex or Home

Job Description

Background:

 Our client is an eClinical software and mobile appliances provider. It offers its own platform for eTrial design, paper and eData capture, monitoring, coding, data management and reporting. The platform’s unique architecture uses distributed computing and mobile technologies to provide the freedom to manage any type of data type, for any protocol, anywhere.  It is purpose-built to respond on-demand to the dynamic needs of study teams: 

¡  Support both simple and complex protocols right out of the box

¡  Operate globally wherever investigators and patients are located

¡  Incrementally go live, speeding study start-up

¡  Execute amendments without system downtime or site interruption

¡  Analyse results through real-time reporting of global clinical data

 Summary:

 This position will be responsible for developing and closing sales of our client’s software product. It will be responsible for all parts of the sales process: generation and development of leads, inside and outside sales calls, tailoring of presentations and proposals to specific customer needs and facilitation of proposals through customers’ approval processes.

The successful candidate will be a relentless new business “hunter” with established connections in the pharmaceutical, biotechnology or life sciences technology sales marketplace. He or she will be excited about the prospect of helping customers break away from limited legacy, “siloed” technology models by moving to our client’s technology.

 The Role:

 The Business Development Manager/Director will perform activities from lead generation to sales closure in line with quarterly and annual sales targets and quotas.

¡  Prospect (i.e., “hunt”) for new accounts, focusing on areas of our client’s technology’s competitive differentiation, maintaining clear account records of points of contact, potential budgets, etc.

¡  Qualify and develop leads into closed technology sales: on-premise licensing, software-as-a-service licensing and professional services sales

¡  Manage tailoring of individual account plans, inclusive of proactive customer proposals and prepared responses to customer RFIs, RFPs and RFQs

¡  Manage customer expectations in line with our client’s technology value proposition and capabilities

¡  Monitor industry trends and quickly adapt to changing developments

¡  Comply with our client’s business practices regarding capture and reporting of opportunities and sales.

 This position will report to our client’s Senior Director of Business Development.

Experience/Qualifications required

Skills and Experience:

 Necessary

¡  Demonstrated ability to build and maintain a strong sales funnel

¡  Demonstrated experience directly selling software and information services-based solutions in R&D divisions of pharmaceutical, biotech or life sciences organisations

¡  Demonstrated experience selling at multiple levels and entry points into life sciences organisations: clinical, IT and financial—from line manager to executive

¡  Proven track record of consistent quota achievement

¡  Demonstration of excellent written and oral communication skills, including the ability to tailor presentations and proposals to specific customer needs

¡  Willingness to travel 20-40% (to see customers, attend conferences, etc.)

 Desirable

¡  Experience selling electronic data capture (EDC) or clinical data management system (CDMS) technology

¡  Experience selling Software-as-a-Service (SaaS), Cloud Computing, or Application Service Provider (ASP) technology

¡  Familiarity with Internet-based, mobile or appliance technologies

¡  Educational background (or equivalent experience) inclusive of medicine, biology, biotechnology or similar field

¡  Ability and desire to work in an entrepreneurial environment

 Qualifications:

 ¡  Bachelor’s degree in Business Administration, Technology or Marketing (or equivalent industry experience).

Global Head of Database Programming

Reference number: 1921 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sussex

Job Description

Job Description:

We are assisting a specialist CRO in finding a Global Head/Manager of Database Programming.

 Core Responsibilities:

To develop the Database Configuration and SAS Programming Group on a global (US and EU) basis. To manage the build, maintenance, ongoing support of trial database applications, and the generation and maintenance of database listings for data management operations according to agreed timelines and quality targets.

 

Principal Accountabilities:

• To recruit and train suitable personnel for the Database Configuration and SAS Programming Group, developing a US group of adequate size and training to act independently of other offices (US secondment priority)

• Manage priorities for the global department to ensure delivery of all trial database applications, data listings (monitoring, coding and safety), reports and delivery of validated reporting shells according to agreed timelines

• Manage, coach, develop and co-ordinate existing members of department (US and UK).

• Coordinates trial database application delivery with software release structure.

• Instrumental in the development of company and/or sponsor standards to allow rapid accurate database configuration.

• Provide input to functional requirements to support the quality and productivity of database configuration.

• Maintain up-to-date knowledge of new developments/functionality specific to database configuration of software as new versions are developed and convey this knowledge to others

• Develops departmental processes and procedures. Leads process initiatives as required.

• Creates screens, visit schedules according to annotated CRF and database specifications.

• Programs and tests validation checks according to Data Management Plan (DMP) specifications.

• Provides input as appropriate into all meetings, discussions and activities pertaining to  database configuration and SAS mapping

• Ensures timesheets are accurate and updated regularly.

• Support Business Development activities as required

Experience/Qualifications required

Candidate Requirements:

• Degree in life sciences, computer sciences, pharmacy, nursing or nursing qualification (e.g. RN) or equivalent relevant experience.

• Demonstrated experience in the disciplines of data management/database programming.

• Previous experience of managing and developing a team.

• Exposure to concepts of clinical database applications and platforms with a knowledge of eDM and eDC processes

• Foreign language skills would be advantageous.

 

Attributes Include:

• Good organisational skills, plus an understanding of resource & budgeting

• Good interpersonal and communication skills and the ability to operate effectively in a global working environment.

• Good people management and coaching skills

• Work calmly under pressure and meet deadlines

• Professional, positive and enthusiastic attitude

• A good investigative and meticulous approach to all activities and tasks

• Transparent approach, clear and precise

• Team player

• Contribute to improving the effectiveness of the organisation such as developing new processes, systems and client relations

• Work effectively and efficiently with internal partners

 

This is a permanent position.

Medical Writing/Regulatory

Last updated: 10:01 05/03/2013

Medical Writer

Reference number: 2004 Apply for this job Apply for this job »
Type: Contract, part time Location: Office based in Ely, UK

Job Description

Salary and Benefits:                       £25k to £30k. For more senior candidates consideration will be given to a salary in the range £30k to £35k.

 Benefits are after 6 months probation period:   Company pension scheme (company 5% employee 3%), Private Medical Insurance, Life Assurance, Medical Benefit scheme. 

 A Childcare Voucher scheme is also in operation.

 
   Summary:

The primary function of this position is to prepare high-quality biomedical communications for the company’s clients, on time and within budget. In this role, the Medical Writer will work closely with other departments within the company and with the company’s clients.

 The Role:

 § Act as primary contact both within the company and with the client for specific projects.

§ Preparation of high-quality biomedical communications that meet the client’s goals in terms of content and timescales.

§ Involvement at all stages of the communications process, from preparation of the writer’s brief, through data/information review, writing and editing, to publication.

§ Liaise with the client, if necessary, to ensure that all resources necessary for a biomedical communications project are available and be receptive to the client’s requests.

§ Maintain up-to-date knowledge of key therapeutic areas.

§ Maintain up-to-date knowledge of new communications media.

§ To perform other reasonable tasks as requested by the company’s senior management staff.

Experience/Qualifications required

Skills and Attributes:

 § Excellent written and oral skills.

§ Excellent accuracy and attention to detail.

§ Good knowledge of Microsoft Word, Excel, Outlook and PowerPoint, and internet search methods.

§ Good organisational and interpersonal skills.

§ Ability to work alone or within a team.

§ Ability to manage competing priorities in a changeable environment.

§ Ability to work to tight deadlines.

 Experience:

 § A minimum of 2 years of medical writing experience gained within a communications agency or the pharmaceutical or healthcare industries.

§ A minimum of 2 years of experience of reviewing work and/or coaching.

 Qualifications:

 § Qualified to at least degree level in a life sciences subject.

Senior Manager, Medical Writing

Reference number: 2002 Apply for this job Apply for this job »
Type: Permanent, full time Location: Marlowe, Office based

Job Description

Summary:

Author regulatory documents for clinical research, including clinical study reports, clinical sections of common technical documents, investigator brochures, protocols, and other clinical documents.  As a lead writer, track and prioritise team writing projects, contribute to regulatory strategy, and coordinate efforts of contributing writers with oversight of senior staff.  Provide medical writing input into clinical development processes, templates, and SOPs.

The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organisation.  Other activities, special projects and assignments may be given as required.  As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organisation as a whole.

Leads the medical writing team to maintain focus on quality medical writing deliverables against defined project timelines and priorities.

The employee must conduct his/her work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all company policies, and procedures. Company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives

 The Role:

 Clinical Document Preparer

Prepares clinical study reports for phase 1, 2, and 3 clinical research studies in support of regulatory submission of drugs and biologics worldwide.  Acts as the lead writer for key clinical study reports, clinical trial protocols, investigator brochures, and other clinical documents.  Coordinates compilation of required attachments and appendices, and oversees review and final publication.  Works with all contributing departments to ensure that all necessary information is organised and summarised effectively.  Ensures that clinical study reports accurately reflect study results and coincide with R&D strategies and regulatory requirements.  Tracks, prioritises, and manages team writing projects.

 CTD Author/

Manager

Serves as lead writer on regulatory filings and other large medical writing projects.  Develops the format and writes the content of clinical sections of common technical documents, and coordinates the review and final publication of these sections.  Serves as a core product team member, contributes to regulatory strategy, and develops working time lines.  Organises and manages other medical writing aspects of the CTD, including the coordination of efforts of contributing writers.

 Leadership and People Development

 Responsible for the role which includes providing leadership, support, and influence to ensure timely and quality deliverables. Hire, train and manage performance of staff (inclusive of orientation, personal development, completing and administering performance evaluations, reward and recognition). Works closely with Human Resources and/or temporary staffing/contract agencies to ensure timely hiring of qualified resources. Actively promotes empowerment and accountability.

 General Compliance and Other Role

The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as the company’s policies, SOPs and Work Instructions.  Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.

  

Experience/Qualifications required

Skills and Attributes:

 Role Name

Proficiency

Clinical Document Preparer

Highly Skilled

CTD Author/Manager

Highly Skilled

Leadership and People Development

Highly Skilled

 Essential Skills

Proficiency

Cross Functional Relationships

Highly Skilled

Communication Skills

Highly Skilled

Decision Making

Highly Skilled

Execution/Results/Process Improvement

Highly Skilled

Customer Satisfaction

Highly Skilled

 ·         Excellent medical writing skills with ability to analyse and interpret clinical and scientific information and to summarise findings in an objective and concise manner.

·         Excellent planning, organisation, and troubleshooting skills

·         Able to manage multiple medical writing projects that have aggressive time lines with minimal oversight from senior staff.

·         Able to supervise other medical writers, both in-house and contract

·         Proven ability to work independently and effectively in teams

·         Effectively demonstrate leadership and motivational skills

·         Excellent computer skills, including familiarity with document management and publishing systems.

·         Ability to travel 10% of the time.

 Experience:

 ·         Significant and substantial experience in medical writing including  planning, organising, and writing all aspects of the clinical portions of NDA/BLA/MAA submissions from a medical writing perspective in the pharmaceutical industry. 

·         Hands on experience of successfully supervising medical writers in the pharmaceutical industry. 

 Qualifications:

 ·         A bachelor’s degree in a health care, biological sciences, biostatistics, or related field (or equivalent experience), a master’s degree in these fields (or equivalent experience) or a PhD/MD in these fields (or equivalent experience).

·         An advanced degree as well as familiarity with clinical research, biostatistics, and US and European Community regulations relevant to Clinical Development in the pharmaceutical industry is highly desirable.

·         Knowledgeable of US and European regulatory guidelines related to clinical development and regulatory marketing applications

Senior Medical Writer

Reference number: 1967 Apply for this job Apply for this job »
Type: Permanent, full time Location: London, Possibility of some home based

Job Description

Summary:

 The successful candidate needs to be able to consistently produce high quality materials for the pharmaceutical industry and other medical bodies. Global and national travel will be a requirement for this role.

 The Role:

 Researching and developing a range of medical education and communications materials, including meeting outputs, slide kits, posters, oral presentations, multimedia and scientific publications

  • Liaising with clients in the pharmaceutical industry and key opinion leaders
  • Preparing for scientific meetings and providing onsite support
  • Managing projects within their specifications to budget and agreed timelines

 Overall Responsibility

 

  • To perform project orientated tasks according to the brief agreed by our client and its clients, according to the specifications and timelines agreed
  • Tasks will involve medical and scientific writing, reviewing and editing of documents, medical communication plans, slide development and reviews, conference summaries and write-ups, internal document development, internal policy development, scientific and strategic input and liaison with clients and external experts

 Internal Responsibilities

 

  • Manage each assigned project, keeping the client and team informed as to the progress of the project
  • Strategic and scientific input in meetings and project development
  • Manage and plan projects in line with agreed budgets
  • Management and development of product communication plans
  • Review and edit documents developed for internal and external use
  • Develop medical and clinical training materials
  • Work with other team members to agree timelines and project plans
  • Support and mentor junior members of staff
  • Manage and oversee the work of junior members of staff and develop performance plans for staff in accordance with company and personal objectives
  • Manage, develop and maintain project budgets where appropriate

Experience/Qualifications required

Experience:

 

At least 5 years’ experience in medical communications.

Senior Regulatory Affairs Specialist

Reference number: 1932 Apply for this job Apply for this job »
Type: Permanent, full time Location: Nottingham or London

Job Description

Summary:

 The Senior Regulatory Affairs Specialist provides project representation and regulatory management for all stages of the drug development cycle.

 The Role:

Tasks may include:

  • Liaise with the Regulatory Affairs Manager/Regulatory Affairs Director to plan, organise, compile, progress and submit regulatory submissions on a timely basis
  • Coordinate and manage regulatory and ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
  • Provide advice on appropriate regulatory strategies
  • Stay abreast of changing regulatory legislative requirements and maintain regulatory intelligence database
  • Contribute towards the preparation of technical reports, which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions.
  • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc., to ensure compliance with ICH GCP and country specific requirements
  • Effectively communicate status of submissions with the Sponsor, Head of Regulatory Affairs, Project Manager, CRAs, Medical and Scientific Affairs staff.
  • Comply with SOPs, ICH GCP and national regulations as applicable
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
  • Deputise for the Regulatory Affairs Manager/Director as required 

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Experience/Qualifications required

Skills:

 

  • Clearly, proven organisational management skills are essential attributes
  • Strong planning, strategising, managing, monitoring, scheduling, and critiquing skills
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Ability to exercise sound judgment and make decisions independently
  • Excellent self-motivation skills
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint   
  • Good knowledge of ICH GCP
  • Good knowledge of EU Clinical Trials Directive

 Experience:

 Previous experience within the pharmaceutical/CRO industry.

 Qualifications:

 Bachelor's Degree in Chemistry or Life Sciences, nursing or equivalent experience.

 Contact:

For more information or to make an application, please contact Philip North at NorthWise Services, as follows:

Telephone: +44 (0) 1795 411 571

Other

Last updated: 11:39 22/02/2013

Business Analyst

Reference number: 1999 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex, Office based

Job Description

Summary:

 Business Analysts are responsible for engaging with product owners, elaborating requirements and presenting these to the engineering and test teams.  As the engineering and test groups work in an Agile manner, the Business Analysts may also carry out Retrospectives (understanding of the successes and possible shortcomings of earlier sprints).  Other responsibilities will include proactive involvement in evolution of processes, both relating to the Business Analysis as well as assisting broader process needs.

 

 

The Role:

 

·         Express and present requirements provided by product owners to Programming and Test teams

·         Present precise and accurate descriptions of customer requirements

·         Engage in productive collaboration with internal and external customers

·         Take active position in describing and advancing processes relating to Business Analysis activities

·         Lead, support, create and follow SOPs and other internal processes

·         Support and provide guidance to teams working in an agile framework

·         Perform Retrospectives (post-sprint analysis) for internal teams as required

·         Work with UX Designers and Information Architects to assist in the production of mock-ups and wireframes for UI development

·         Continual updates to domain knowledge for areas covered by the company’s software platform and any associated company products/developments

·         Provide accurate and timely reporting to the Head of Section

Experience/Qualifications required

Skills and Attributes:

 Demonstrated ability to express requirements from product owners to engineering and test teams

  • Easy working manner supporting productive collaboration with internal and external customers
  • Excellent presentation, coaching and facilitation skills. Ability and enthusiasm for delivering training solutions
  • A strong customer service orientation with an excellent telephone manner
  • Excellent organisational skills
  • Excellent interpersonal and communication skills, and the ability to operate effectively in a global working environment
  • Ability to listen and interpret technical actions in a non-technical manner
  • Work calmly under pressure and meet deadlines
  • Professional, positive, dynamic and driven
  • A good understanding  of clinical terminology
  • Ability to prioritise activities in line with client business needs
  • A good investigative and meticulous approach to all activities and tasks
  • Team player
  • The ability to work effectively and efficiently with internal partners within the company

 Experience:

 Proven experience of presenting precise and accurate descriptions of requirements

  • Working experience within an Agile environment
  • Experience working with a Pharmaceutical company, or organisation operating in a regulated environment
  • Experience working within a software development group, including collaboration with User Experience designers and Information Architects
  • Experience working with the Atlassian Confluence application
  • Experience working with Jama Contour requirements management application

 Note : The last 4 of the experience requirements are preferred only and not essential.

 Qualifications:

 Degree educated - postgraduate experience would be beneficial

Senior Safety Systems Analyst

Reference number: 1993 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Office based in Welwyn Garden City, UK

Job Description

The Role:

*  Provides leadership to the PVIS team in conjunction with the PV Information and Systems Manager

* Deputises for the PV Information and Systems Manager as appropriate

*  Analyses and solves a wide range of complex process and system related problems in all areas of PVIS’s responsibility

*  Develops and/or performs custom database searches and outputs through tools like SQL, Business Objects or SAS, to support PVIS processes

*  Works with the safety systems user community to define requirements for standard reports, and implements, tests and documents these reports

*  Provides change management, master data maintenance and front-line application support for applicable Drug Safety systems on behalf of PDS

*  Performs global safety database activities, global regulatory submission activities, basic safety data searches and reporting

*  Content management using information management tools like DSO and QTT

* Assesses, evaluates and implements technology enhancements to support global and local business processes

* Interacts with Drug Safety functional groups, other information management functions in Development, IT organisations, external business partners, vendors and health authorities

*  Represents the PVIS group in department and cross-functional initiatives

*  Creates or reviews requirements, specifications and business process documentation

*  Designs logical and innovative solutions to complex problems

*  Participates in global, cross-functional activities and projects, i.e. within PDS, as well as affiliates and other PD functions

* Provides support, administration and change management for existing Drug Safety systems

*  Maintenance of the systems’ Master Data (i.e. business configuration) such as user account management, regulatory reporting rules, document templates, protocols, drug dictionaries

*  Acts as a process owner for Master Data activities and works closely with the management team to ensure that the process remains effective and works efficiently

*  Ongoing review of PV Information and Systems processes to provide suggestions for continuous improvement

 

*  Prepares, delivers and maintains training overview of all new starters as part of Global PDS Induction Programme

 

*  Prepares and delivers training to Global PDS required for the implementation of any process or system change

 

*  Provides support and mentoring to other PV Information and Systems Group members

 

*  Performs and documents user acceptance testing on submission rules and associated processes

 

*  Ability to interpret business and regulatory reporting requirements to enable system users to comply with current guidelines and plan for future changes

 

*  Works closely with Informatics colleagues (FIGL) to identify and implement technology solutions to meet business requirements

 

*  May be required to travel        

 

The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

 

Experience/Qualifications required

Skills and Attributes:

 *  Drug Safety knowledge or other relevant experience in the drug development environment within the pharmaceutical industry

*  Strong technical knowledge in database technologies, and query and reporting tools, such as SQL, Business Objects and SAS

*  Thorough knowledge of the application of software solutions to complex business problems in a validated environment

*  Excellent communication skills to analyse problems and discuss solutions with colleagues, project team members and users

*  Extensive prior experience with analysis and reporting of drug safety and/or clinical trial data

*  Knowledge of drug safety regulatory obligations and guidelines

*  Working knowledge of medical terminologies, e.g. MedDRA

*  Working knowledge of industry standard safety systems

*  Computer literacy

*  Fluent in English

* Able to work independently and to act with a minimum of supervision

*  Generates enthusiasm and drive for commitment to excellence

*  Able to design innovative solutions

*  Displays a high level of commitment

*  Works well in a team environment

*  Proven good communication skills

*  Can deliver informative, well-organized presentations to team and management

*  Good attention to detail

*  Confident decision maker

*  Demonstrates analytical and problem solving skills

*  Good time management and organisational skills

*  Structured/ methodical approach to work

 

Qualifications and Experience:

 

*  Life Science/ Computer Science qualification or other relevant career experience

Senior Technical Analyst

Reference number: 1943 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Berlin

Job Description

Summary:

 Provide technical expertise as well as conduct specification development and functional testing.

General areas of responsibility include: specification creation, clinical database testing and development of the specifications for data consistency checks programming, test data creation and functional testing, import/export programming functional testing and specification development, as well as mapping specifications to support relevant data standards. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

 The Role:

 Relationships

Reports To Associate Manager or above

Directly Supervises N/A

Provides Work Direction to Technical Analysts, Clinical Database Programmer(s) as appropriate

Works Closely with Line Managers, Clinical Database Programmers, Technical Analysts,

Quality Management Group (QMG), Project Team Members, Data Operations Leader, Clinical Data Analysts (CDAs), Information Services (IT), Biostatisticians, Technical Integration Architects (TIAs), Statistical Programmers and other GRO project members

External Relationships

Sponsors, External Vendors

Experience/Qualifications required

Skills:

 • Influencing and negotiation skills including working in a global team environment

• Strong customer focus with a service mentality.

• Ability to manage multiple and varied tasks with a high quality standard.

• Attention to detail and strong organisational skills.

• Ability to work independently and prioritise a diverse workload.

• Very good understanding of System Life Cycle process and applicable regulations pertaining to Computer Systems (e.g. ICH-GCP, 21 CFR 11).

• Relevant experience in maintaining and supporting of processes in a distributed client base within a regulated environment.

• Proficiency in a programming environment and understanding of relational databases.

• Very good understanding of IT and the departments within GRO.

• Excellent analytical skills and attention to details

• Dedicated skills such as clinical development process and related data standards.

 Language Skills

• Excellent English written and oral communication skills

 Experience:

 • Relevant work experience required

 Qualifications:

 • B.C.A./M.C.A./M.Sc./B.S./B.Sc./B.A. in a science or industry-related discipline

Technical Analyst

Reference number: 1942 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Berlin

Job Description

The Role:

 General

  • Write specifications and perform functional testing of electronic as well as paper clinical databases and validation programming
  • Develop and maintain a good understanding and working knowledge of department-specific technologies, as well as other relevant systems
  • Design, specify and review Case Report Forms (CRFs, eCRFs), and incorporate feedback
  • Translate protocols into requirements for the clinical database and develop corresponding specifications for database programming, and data load/export
  • Provide input into other Programming Group activities as required
  • Work closely with the Quality Process and the Training Learning Group to ensure compliance with SOPs/Work Instructions/Guidelines, ICH-GCP and any other applicable local and international regulations

 Quality Checks and Testing

  • Create test scripts and test data for all the CDMS and EDC technologies
  • Generate test data for all QC of programs
  • Develop specifications and test plans and scripts to support the functional testing of systems
  • Set up, test and approve existing relevant tools, as well as ensure that this has been documented in the standard QC checklist and that the process is compliant to the tool utilised.
  • Participate in internal/external audits and regulatory inspections as required.

Perform quality control on all technical activities related to trial set-up and processing

 Documentation

  • Provide technical guidance to other team members
  • Create and maintain Clinical Database Documentation

 

Programming and Systems and Data Standards

  • Implement applicable standards for clinical database specifications
  • Develop mapping specifications for data exports in accordance with applicable standards
  • Understand the architecture of a system, as well as the impact of database/program changes and what touch points are required to be re-tested

 

Experience/Qualifications required

Skills:

 Proficiency in a programming environment and understanding of relational databases

  • Excellent English written and oral communication skills
  • Influencing and negotiation skills including working in a global team environment
  • Strong customer focus with a service mentality
  • Ability to manage multiple and varied tasks with a high quality standard
  • Attention to detail and strong organisational skills
  • Ability to work independently and prioritise a diverse workload
  • Very good understanding of System Life Cycle process and applicable regulations pertaining to Computer Systems (e.g. ICH-GCP, 21 CFR 11)
  • Excellent analytical skills and attention to details
  • Dedicated skills such as clinical development process and related data standards

 Experience:

 Exposure to at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)

 Qualifications:

 Bachelors or Masters degree in a science or industry-related discipline

 

NET Web Developer

Reference number: 1918 Apply for this job Apply for this job »
Type: Permanent, full time Location: London

Job Description

The Opportunity

 To join a well established business that is recognised as the leader in EDC and Data Management solutions in Early Phase Clinical Trials.  The Life Science and Pharmaceutical Industries represent rapidly expanding markets, where the potential for technologically lead solutions are still enormous, especially given that the clinical trial environment was relatively slow in adopting and utilising such technologies and still rely very heavily of paper based solutions.

 Within Logos you will be given the freedom and autonomy to be their .NET expert and take the lead in developing the company’s new interface for their ALPHADAS web-based portal.  This is critical to the vision of this Software business and as such you work closely with, and report directly into, Logos’ Managing Director, Giles Wilson.

 Job Purpose and Responsibilities

 ·                                       To become Logos’ expert and lead in .NET development processes.

 ·               Working from a completely blank canvas, you will act as front-end developer, using Windows.NET 3.5 to design a fully functional, visually pleasing directive customer interface for Logos’ ALPHADAS EDC web portal.

 ·               To write highly professional and clearly structured code that will ensure high performance & user satisfaction and will enable this new interface to efficiently communicate with Logos’ central database application. 

 ·               Update and improve the presentation layer - the layout and visual impact of this interface will be critical to its success, so you will need to be highly creative and have a strong understanding of how the interface should look in terms of positioning, designs and use of colours.

 ·               To work closely with other specialist developers to create a new fully functional EDC system.

 ·               Keep up to date with how new technologies are developing and how platforms are likely to evolve.

 ·               Improve communication layers between web browsers and database servers.

 

Experience/Qualifications required

Ideal Candidate Profile

 ·               A proven ability to designing directive, fully functional interface data systems

·               Technical and theoretical knowledge and understanding of;

.NET 3.5, SQL, JAVA script, XML and HTML

·               Highly visually creative – an ability to design code that is visually appealing and user friendly.

·               Knowledge and understanding of Object Orientated design.

·               Have experience of developing technologies within the Clinical or Pharmaceutical sectors.

·               Confidence to operate in client facing situations.

 Core Candidate Profile

 ·               A proven ability to designing directive, fully functional interface data systems

·               Technical and theoretical knowledge and proven understanding of;

Windows.NET

·               Highly visually creative – an ability to design code that is visually appealing and user friendly.

·               A positive attitude and an ability to work independently and as part of a team

·               An understanding of the importance of business critical objectives and a background of delivering development projects to fixed timelines .

·               Ability to work in an agile and fast paced development environment.

·               An individual that will thrive in a technology lead entrepreneurial dynamic small team environment.

 Soft Skills

 ·               Excellent communication and organisational skills

·               Highly self-motivated detail orientated and quality driven individual

·               Strong written and oral skills and confident in client facing situations.

·               Enthusiastic, inquisitive and keen to continue in their professional learning.

 Remuneration and Package

 £30,000 – 40,000 base salary with opportunity to generate bonus payments upon successfully delivering against set objectives.

Metabolic Modeller

Reference number: 1897 Apply for this job Apply for this job »
Type: Permanent, full time Location: Hertfordshire

Job Description

Summary:            The aim is to genetically engineer microorganisms to convert sugars to bulk organic compounds, and the metabolic modeller will play a key role in devising and optimising routes to enhance carbon flux to maximise yield.

 The Role:                  

 ·         To develop and apply metabolic models in microorganisms

·         To model the effects of genetic manipulations to metabolic pathways and to refine the models based on the results from genetic engineering

·         To apply metabolic modelling and knowledge of biochemical pathways to devise novel biosynthetic routes to target molecules and strategies to optimise yield from sugars

Experience/Qualifications required

A PhD in metabolic modelling, molecular biology or bioinformatics plus postdoctoral experience in relevant areas

A good working knowledge of metabolic pathways and basic biochemistry

Experience in applying metabolic modelling in a microbial system

Some experience of practical molecular biology or microbial genetics would be an advantage

Pharmacovigilance

Last updated: 15:12 06/03/2008

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Project Management

Last updated: 11:41 22/02/2013

Project Manager

Reference number: 2000 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex, Office based

Job Description

Summary:

 Act as key point of contact for assigned company Business Transformation Clients.  Be responsible for the creation and management of Client expectations in terms of agreed project deliverables to enable achievement of a positive and productive working relationship.

 The Role:

 ·         Take overall project management responsibility of assigned projects and their deliverables

·         Balance Client needs with those of the company’s Business Transformation to create and maintain a positive working relationship with both parties

·         Be conversant with the responsibilities, limitations and budget framework described by the Master Service Agreement and associated Task Orders for assigned projects

·         Facilitate proactive communications between project stakeholders to support project delivery

·         Act as consultant to the Client on the adoption of the company’s “best practice” and their achievement of Return On Investment (ROI)

·         Identify project related issues, facilitate resolution and escalate to senior management where necessary

·         Proactively identify potential process improvements to increase operational efficiency, including implementation of improvements once agreed with senior management

·         Lead identification of, and facilitate the sharing of “lessons learned” across Professional Services, the company’s Technology or the company’s Group as appropriate

·         Work with Professional Services Client Program Managers to coordinate assigned project resources to achieve agreed project timelines

·         Review client proposals and associated budgets and provide feedback to the company’s Contracts and Proposals team when requested

·         Monitor project Full Time Equivalent (FTE) actuals versus allocated budget.

·         Track project profitability, identify potential changes in scope and document as agreed with senior management

·         Update the the company Group financial tracking system on a monthly basis to indicate actuals for assigned projects and flag invoice milestones

·         Supportthe company’s Sales and Marketing team as required

·         Other activities as deemed appropriate by line manager

 

Experience/Qualifications required

Skills and Attributes:

 ·         Excellent written and verbal communication skills

·         Confidence in dealing with diverse range of customers

·         Awareness and working knowledge of relevant regulatory guidelines e.g. 21CFR11

·         Demonstrable understanding of Electronic Data Capture and Data Management systems and/or process

·         Ability to lead and direct distributed teams

·         Knowledge of project management principles and execution

 Experience:

 ·         At least 3 years’ experience of external client management

·         Experience of project budget management

Study Support Specialist

Reference number: 1979 Apply for this job Apply for this job »
Type: Contract, full time Location: Stockley Park, UK

Job Description

Summary:

 This is a demanding, responsible, varied and challenging role, which requires a basic understanding of the clinical development process.   The position would be suitable for someone who is self motivated, can multitask and is able to use clinical development systems and tools independently with an understanding as to why these tools are used.  The successful candidate will provide first class support to the Clinical Team, including senior members of the Oncology Therapy Area Management Team.

 The Role:

 Key Responsibilities

 Provide comprehensive support to Clinical Team to include but not limited to :

 ·         Provide operational support to clinical study/studies.

·         Responsible for currency and accuracy of database systems e.g. e-Track.

·         Order drug/non-drug study supplies.

·         Ensure receipt and quality of regulatory and financial documents.

·         Initiate and oversee FID activities.

·         Provide paper/electronic documentation to support modular appendices for clinical study reports.

·         Set up and maintain study files and related documentation.

 Purpose

·         Provide operational support for delivery of assigned studies or programmes on time

·         Responsible for accuracy of database systems

·         Adhere to the GCO - EU model, collaborating with internal key matrix partners and external customers

 Key Responsibilities for all Areas

·         With oversight, enter and maintain information in systems; produce standard reports; check own work and correct errors; produce and disseminate information from standard reports

·         Provide support or assistance to group/clinical teams as directed

·         Participate in the implementation of key organisational process improvement initiatives as appropriate

·         As appropriate, contribute to the standardisation and dissemination of best practices across area

·         Complete administrative duties as required

·         Resolve routine requests, escalate complex requests

 Regional Monitoring

·         With oversight, participate in efforts to assure site selection /recruitment process conducted per study timelines.  As directed, compile and send updates on the site selection recruitment process to monitors and managers.  

·         As directed by Regional Monitoring Head or monitor liaison, work with study conduct team to track study start-up and enrollment status and communicate to monitors.

·         Participate in efforts to conduct study feasibility in the region per defined processes.

 Study Management/Therapeutic Areas

·         Order, assemble, distribute, manage and track inventory of study conduct tools, drug and non-drug clinical supplies.

·         With guidance, set up, obtain, and maintain sponsor regulatory, legal, CSSO and financial files/systems per SOP, including submitting of documents to appropriate departments.

·         Assist in providing paper/electronic documentation to support modular appendices for Clinical Study Reports.

 Document Management

·         Set up, obtain, and maintain sponsor study records according to GCP/GSK processes

·         Partner with Study Management in conducting sponsor clinical study records file review

·         Archive sponsor study clinical records

 Clinical Study Agreement Team (CSAT)

·         With oversight, assist in preparing Clinical Study Agreements (CSAs) for clinical sites.

·         With oversight, maintain and update shared areas and databases for CSAs.

·         With oversight, handle routine agreement requests from Study Management and CSAT regarding CSAs.

Experience/Qualifications required

Skills:

 Minimum Requirements
 ·         Understanding of the clinical development process at study level and how parts of the process are integrated.

·         Understanding of the R&D process.

·         Computer proficiency

·         An excellent organiser, able to work well under pressure and to tight deadlines.

·         Ability to work both independently and as part of a team.

·         Personal attributes should include ability to act with discretion, initiative and diplomacy at all times.  Flexible approach with a "can do" attitude and ability to prioritise.

 Detailed Requirements

 ·         Computer proficiency in a variety of software applications

·         Basic knowledge of clinical development processes, including related functional areas and FDA regulations as required

·         Ability to work on complex or multiple project assignments

·         Demonstrated ability to manage tasks with limited oversight

·         Exhibit customer service orientation and interpersonal skills

·         Basic understanding of portions of the clinical development process such that employee is able to carry out the process as it is currently

·         Is able to use clinical development systems and tools as directed and understand why tools are used

·         Makes basic decisions regarding methods of working with guidance; complex decisions with oversight

·         Adaptability: With supervision, demonstrated ability and willingness to adjust behaviours and priorities based on changing environment

·         Integrity: Meets personal commitments and promises, and fairly represents the organisation’s capabilities, while adhering to policies and regulations; shares complete and accurate information while maintaining confidentiality

·         Communication: Demonstrated effectiveness in both oral and written communication

·         Teamwork/Collaboration: Is aware of and responds to needs of others in x cross-functional teams; actively promotes teamwork and provides input into objectives and accomplishments; offers input and ideas during team meetings

·         Customer Service Orientation:  Recognise customers, develop customer relationships by making efforts to listen to and understand the customer (both internal and external); meet or exceed customers’ needs

·         Work Standards: Sets high performance standards for self

·         Practical Learning: Assimilates and applies new knowledge and skills quickly

·         Planning and Organising: With supervision, ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards

·         Problem Assessment: Detect problems and opportunities; identify key issues and relationships from a base of information; gather all relevant information

·         Negotiation: Explore needs, concerns, and positions of others

·         Initiative: Self-starting rather than accepting passively

Director, Project Management

Reference number: 1969 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex

Job Description

Summary:

 To manage and lead the Technology Project Management Team, represent our client  with external and internal customers.  Lead release planning to ensure our client’s technology releases meet timeline and customer expectations

 The Role:

 Liaison with Business Development in contract preparation, bid defence and ongoing client account management

  • Act as a "customer representative" within the group to ensure adequate understanding and appreciation of customer requirements.
  • Assist in prioritisation of our client’s EDC system functionality development
  • Manage the relationship with, and expectations of our client’s customers.
  • Act as escalation point for all issues relating to our client’s customer management
  • Review escalations from the study team on a regular basis and action suitable responses.
  • Management of project assignments to individual Project Managers
  • Line management and mentoring support of assigned teams.
  • Ensure adequate training of team members relative to the tasks required
  • Lead performance appraisal reviews for assigned teams
  • Ensure project management SOPs are appropriate and followed.
  • Provide leadership support to the project management and extended teams in meeting timeline and customer expectations
  • Manage project management resource planning, forecasting, recruitment, etc
  • Ensure teams operate within assigned budget limits

Experience/Qualifications required

Skills:

 ·         Fully aware of regulatory requirements for EDC systems e.g. 21CFR11, etc

 
 Experience:

 ·         At least 12 years experience in managing external customers

·         At least 6 years direct experience of managing EDC technology teams

·         Direct experience of electronic data capture platforms and clinical trials process within a regulated Pharmaceutical environment

·         Experience of line management within a project management environment

Senior Medical Project Manager

Reference number: 1929 Apply for this job Apply for this job »
Type: Permanent, full time Location: Cambridge

Job Description

Summary:

 Our client is a global innovation, technology and product development company providing outsourced R&D consultancy services to start-ups through to global market leaders in the medical, industrial and consumer sectors. With global headquarters in Cambridge, UK and US headquarters in Cambridge, Massachusetts, our client works with end clients from front-end market needs analysis and product development through to transfer to manufacture.

 Our client is looking to recruit a technically capable and hands-on Project Manager to work on a variety of assignments for customers in the medical sector, a rapidly growing business area for our client.

Experience/Qualifications required

Sorry, full job requirements are not currently available for this job

Quality Assurance

Last updated: 12:57 19/03/2012

Manager, Quality Assurance

Reference number: 1965 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based, Norfolk

Job Description

The Role:

  Supporting the Manager, Quality and Process Improvement, in

development of the Quality System to meet regulatory, sponsor and

business requirements

 Management of the company internal audit programme

 Managing the supplier and sub-contractor approval programme

 Collation, reporting and monitoring of compliance with internal

procedures and regulatory requirements

 Hosting and managing sponsor audits and co-ordination of responses

and follow-up

 Develop staff training programmes in order to ensure regulatory

compliance

 Involvement in regulatory inspections as required; key role in planning

and follow-up of GCP inspections

 Development of CAPA (corrective action preventive action) plans to address quality issues and non compliances

Experience/Qualifications required

Experience:

  Experience and knowledge of Good Clinical Practice

 Experience of developing and improving quality systems

 Supervisory or management experience

 Experience of planning and conducting internal audits and audits of

suppliers and sub-contractors

 Experience and knowledge of equipment and computer systems

validation requirements to comply with the principles of Good Clinical

Practice

SAS® Programmers

Last updated: 11:31 22/02/2013

SAS Programmer

Reference number: 1996 Apply for this job Apply for this job »
Type: Permanent, full time Location: Stirling, Scotland

Job Description

Background:

 Our client, a dynamic and growing CRO with European HQ, is expanding its UK based data and statistics team.  The company has more than 18 years’ history of providing ISO certified clinical development services to the pharmaceutical, biotechnology, vaccine and medical devices industries.  With over 500 employees across Europe and the USA, the company has a commitment to provide coaching and training for all, to ensure that a high quality service is delivered to clients and that employees develop to their full potential.  The role is based in Stirling , Scotland in an office environment which encompasses the full clinical team.

The Role:

 The SAS Programmer will join an ever expanding team of clinical professionals and contribute to the successful delivery of high quality services to clients.  The SAS Programmer responsibilities include:

 Supporting statisticians in programming inferential analysis, tables, figures, listings and randomisation in SAS

  • Helping with the organisation and conduct of a quality control review of the inferential analysis, tables etc
  • Preparing and archiving all datasets, computer programs and other materials arising from the preparation of tables, listings etc
  • Developing and maintaining SAS programs and SAS full screen applications
  • Contributing to the development of SAS programming and related SAS applications

 

Experience/Qualifications required

Skills and Attributes:

 Fluency in English, both written and verbal, is a necessity.

 Experience:

 At least 2 years experience in SAS/biostatistics, preferably in a CRO or pharma environment.

  Qualifications:

 A degree in sciences.

 You will need to have together with at least 2 years SAS experience to be considered for this interesting role. 

 

SAS Programmer

Reference number: 1995 Apply for this job Apply for this job »
Type: Permanent, full time Location: Stirling, Scotland

Job Description

Summary:

 Our client is an international, full-service Contract Research Organisation. For more than 14 years it has provided ISO certified clinical development services to the pharmaceutical, biotechnology, vaccine and medical device industries for products and devices in a broad range of therapeutic areas.

The Role:

  • Supporting statisticians in programming inferential analysis, Tables, Figures, Listings and randomisation in SAS
  • Helping in organising and conducting a quality control review of the tables, listings figures and inferential analysis
  • Preparing and archiving of all datasets, computer programs and other material used in the preparation of the tables, listings, figures, inferential analyses for the integrated study report
  • Developing and maintaining SAS programs and SAS full screen applications
  • Contributing to the development of SAS programming and related SAS applications (including implementation of the quality system for SAS programming)

Experience/Qualifications required

Skills and Attributes:

  • Fluent English written and verbal communication
  • Team player, organised, patient, analytical

 Experience:

  • At least 2 years of SAS/biostatistics experience, preferably with a CRO or pharmaceutical company,  or in academia

 Qualifications:

  • Higher education in sciences, mathematics, statistics or other equivalent scientific training

SAS Programmer

Reference number: 1989 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Office based in London, UK

Job Description

Requirements

 1.    At least 4/5 years of SAS programming experience in pharmaceutical and/or CRO environment as a data management programmer or statistical programmer

2.    Very good SAS programming knowledge (Base SAS, SAS/GRAPH, SAS/STAT, macro programming, reporting, SQL), familiarity with ODS RTF/ HTML

3.    Knowledge of the data management process in clinical drug development

4.    Good knowledge of medical coding processes, standards and issues

5.    Expertise in working with pooled, safety and efficacy data

6.    Good analytical skills

7.    Excellent interpersonal and team working skills

8.    Good communication and presentation skills, both oral and written

9.    Knowledge of regulatory requirements, e.g. CDIS Standards, ICH guidelines for statistical reporting

10.  Comprehensive knowledge of clinical and pharmaceutical drug development process and GCP requirements

11.  Multiple phase experience in clinical research

12.  The ability to work independently and prioritise one’s own workload

13.  Ability and willingness to work from the office in Central London

 

Experience/Qualifications required

Advantageous

A sound understanding of basic statistical principles and the basics of statistical programming

Experience in safety data analysis

Programming skills in any of the following: JavaScript/VBScript, Java, VBA, XML, XSLT, SQL, Microsoft Excel

Exposure to investigational new drug application (IND) annual reports and Development Safety Update Reports (DSURs)

Experience of signal detection in clinical data

Manager, Statistical Programming

Reference number: 1952 Apply for this job Apply for this job »
Type: Permanent, full time Location: Uxbridge or Sheffield

Job Description

Summary:

 Our client is a highly reputed international CRO which is seeking a manager of statistical programming to be ideally based in Uxbridge though our client can also consider Sheffield. Our client can also consider candidates from Associate Manager level through to Senior Manager level.

 As Manager, Statistical Programing you will manage and oversee the activities of a team of skilled programmers at all levels. This will include resourcing of staff, coordination of staff assignments, quality control and overall responsibility for the timely delivery of project deliverables.

 The Role:

 Responsibilities:

 - Train, mentor and allocate team members according to their ability

 - Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.

 - Recruit, retain and develop a skilled, experienced and motivated team.

 - Maintain productivity/billability and staff turnover within agreed level.

 - Participate in and contribute to project bids, including presentations at bid defence meetings.

 - Produce accurate resourcing plans in conjunction with the appropriate project team members.

 - Responsible for own assignments as project team member. This includes taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables.

 - Prepare and submit weekly study specific status reports to project team, sponsors and management and attend project team meetings.

 - Manage and develop the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives

 - Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner

 - Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and SOPs.

 - Participate in company and department system/standards improvement activities

Experience/Qualifications required

Skills and Attributes:

 - Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.

 - Proficiency in SAS and knowledge of the programming and reporting process

 - Demonstrate ability to learn new systems and function in an evolving technical environment

 - Strong leadership ability and excellent communication skills

 - Ability to successfully work together with an international, virtual team as well as independently

 - Demonstrate strong organisational skills, ability to manage competing priorities, and be flexible to change

 - Attention to detail and excellent analytical skills.

 - Tenacity to work in an innovative environment.

 - Ability to negotiate and influence in order to achieve results.

 - Business/Operational skills that include customer focus, commitment to quality management and problem solving.

 - Good business awareness/business development skills (including financial awareness)

 
 Experience:

 - Substantial statistical programming experience including leading clinical trial project teams

 Contact:

For more information or to make an application, please contact Philip North at NorthWise Services, as follows:

Telephone: +44 (0) 1795 411 571

Statistical Programmer II/Senior

Reference number: 1950 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield

Job Description

Summary:

 Our client is seeking a Statistical Programmer II or Senior Statistical Programmer for its offices in Sheffield.

 Essential Functions:

To provide support for the activities of the Data Management and Statistics departments, including the programming of consistency checks/queries, programming/mapping of study data and the production of statistical tables, figures and listings on a project by project basis for Phase I and 2a clinical trials.

 The Role:

 Responsibilities include:

 -Working to ICH GCP and other applicable industry standards

-Liaising where appropriate with data management and statistics groups worldwide

-Liaising with clients as required

-To ensure applicable data management and statistical functions are performed to scheduled timelines

-Programming edit/consistency checks in SAS

-Management of data transfer processes from EDC system (ClinBase) to iVAL/SAS

-Creation and review of statistical analysis plans as appropriate

-SAS programming, including the production of statistical listings, tables and figures as appropriate and the manipulation of datasets into derived datasets.

 

Experience/Qualifications required

Skills:

 •        Proficiency in at least one programming language (e.g., SAS, CDMS, EDC, SQL, VB, Java)

•        Demonstrate ability to learn new systems and work with evolving technologies

•        Attention to detail

•        Demonstrate strong organisational skills, ability to manage competing priorities, and be flexible to change

•        Business/Operational skills that include customer focus, commitment to quality management and problem solving

•        Work effectively in a quality-focused environment

  Experience:

 Minimum Work Experience:

-Demonstrated SAS programming experience in a clinical trials environment

 •        Relevant Clinical Trial industry experience, including experience working with specialised systems (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs)

•        Recent experience within a statistical environment

 Qualifications:

 -Degree or equivalent in a scientific subject

Senior Manager of Database Programming

Reference number: 1949 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex

Job Description

Summary:

 Our client is a highly respected specialist Data Management CRO which is looking for  a Senior Manager of Database Programming for its offices in West Sussex.

 Core Responsibilities:

To develop the Database Configuration and SAS Programming Group on a global (US and EU) basis. To manage the build, maintenance, ongoing support of trial database applications, and the generation and maintenance of database listings for data management operations according to agreed timelines and quality targets.

 Principal Accountabilities:

•        To recruit and train suitable personnel for the Database Configuration and SAS Programming Group, developing a US group of adequate size and training to act independently of other offices (US secondment priority)

•        Manage priorities for the global department to ensure delivery of all trial database applications, data listings (monitoring, coding and safety), reports and delivery of validated reporting shells according to agreed timelines

•        Manage, coach, develop and co-ordinate existing members of department (US and UK).

•        Coordinates trial database application delivery with software release structure.

•        Instrumental in the development of company and/or sponsor standards to allow rapid accurate database configuration.

•        Provide input to functional requirements to support the quality and productivity of database configuration.

•        Maintain up-to-date knowledge of new developments/functionality specific to database configuration of software as new versions are developed and convey this knowledge to others

•        Develops departmental processes and procedures. Leads process initiatives as required.

•        Creates screens, visit schedules according to annotated CRF and database specifications.

•        Programs and tests validation checks according to Data Management Plan (DMP) specifications.

•        Provides input as appropriate into all meetings, discussions and activities pertaining to database configuration and SAS mapping

•        Ensures timesheets are accurate and updated regularly.

•        Support Business Development activities as required

Experience/Qualifications required

Skills and Attributes:

 •        Good organisational skills, plus an understanding of resource & budgeting

•        Good interpersonal and communication skills and the ability to operate effectively in a global working environment.

•        Good people management and coaching skills

•        Work calmly under pressure and meet deadlines

•        Professional, positive and enthusiastic attitude

•        A good investigative and meticulous approach to all activities and tasks

•        Transparent approach, clear and precise

•        Team player

•        Contribute to improving the effectiveness of the organisation such as developing new processes, systems and client relations

•        Work effectively and efficiently with internal partners

•        Foreign language skills would be advantageous.

 Experience:

 •        Typically 5 or more years experience in drug development, at least 3 years in the disciplines of data management/database programming.

•        Demonstrated experience in the disciplines of data management/database programming.

•        Previous experience of managing and developing a team.

•        Exposure to concepts of clinical database applications and platforms with a knowledge of eDM and eDC processes

 Qualifications:

 •        Degree in life sciences, computer sciences, pharmacy, nursing or nursing qualification (e.g. RN) or equivalent relevant experience.

(Senior) Statistical Programmer

Reference number: 1948 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex

Job Description

Summary:

 Our client is a highly respected specialist Data Management CRO which is looking for either a Senior Statistical Programmer or a Statistical Programmer for its offices in West Sussex.

 The Role:

 Core Responsibilities:

 •        Statistical programming for both production and QC of derived data sets, data listings, data summaries, figures and statistical appendices for global phase I-IV trials.

•        Creation of study specifications for analysis datasets and pooled datasets for phase I-IV clinical trials.

•        Responsible for the quality and timeliness of statistical programming deliverables.

 Principal Accountabilities:

 •        Program analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for overall summaries of safety and efficacy to company and/or client specifications.

•        Production of study specifications for analysis datasets and pooled datasets for phase I-IV clinical trials.

•        Provide input as appropriate into specifications for data listings, data summaries/tables and figures for phase I-IV clinical trials, and for overall summaries of safety and efficacy, to ensure adherence to the standards of the company and/or its client.

•        Provide quality control for the above deliverables.

•        Produce SAS programs written to a standard as defined by the company and/or client good programming practice requirements.

•        Clearly document all work ensuring that program and project documentation are maintained to a high standard and on an ongoing basis.

•        Provide programming input into CRF(s) and data management plan(s) to ensure that these documents are consistent and adhere to the standards of the company and/or the client.

•        Provide input from a statistical programming perspective to the statistical analysis plan, the QC plan and project convention documents.

•        Provide input into specifications of data structures and databases to ensure adherence to company and/or client standards.

•        Adhere to pre-defined project/study standards and specifications.

•        Input for specific data types into the estimation of task durations for programming deliverables.

•        Maintain efficient interfaces with internal and external customers in consultation with management.

•        Perform role of programming lead on selected data types on studies.

•        Provide transfer of SAS derived datasets, outputs and programs (as appropriate) from company to Client.

•        Ensure project and resource tracking sheets are accurate and updated as required.

•        Maintain up-to-date knowledge of new developments/functionality of SAS as new versions are released.

•        Actively participate at meetings, discussions and activities covering statistical programming aspects for assigned trials.

•        Provide input to departmental processes and procedures and take part in process initiatives as required by management.

•        Act as a SAS programming consultant to internal customers for projects.

•        Induct and coach programmers as appropriate on technical, trial and project level processes.

•        Provide input to the appraisal process when required.

•        Provide input into recruitment process as required.

•        Ensure timesheets are accurate and updated on a weekly basis.

Experience/Qualifications required

Skills:

 •        Good SAS programming skills (BASE, MACRO, GRAPH).

•        Knowledge and experience in database design and structures.

•        Knowledge of clinical trial practices, procedures and methodologies.

•        Knowledge of statistical principles underlying clinical trials

 Experience:

 •        Previous experience in programming in a clinical trials environment or in a related field.

 Qualifications:

 •        Minimum of BSc/BA or equivalent in computer science, mathematics, statistics, life sciences or related field(s).

 Contact:

For more information or to make an application, please contact Philip North at NorthWise Services, as follows:

Telephone: +44 (0) 1795 411 571

Email: philip.north@northwiseservices.com

Contract (Senior) Statistical Programmer

Reference number: 1946 Apply for this job Apply for this job »
Type: Contract, full time Location: West Sussex

Job Description

Summary:

 Our client is a highly respected specialist Data Management CRO which is looking for a contract Senior Statistical Programmer or Statistical Programmer for its offices in West Sussex.

 Core Responsibilities:

 •        Statistical programming for both production and QC of derived data sets, data listings, data summaries, figures and statistical appendices for global phase I-IV trials.

•        Creation of study specifications for analysis datasets and pooled datasets for phase I-IV clinical trials.

•        Responsible for the quality and timeliness of statistical programming deliverables.

 Principal Accountabilities:

 •        Program analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for overall summaries of safety and efficacy to company and/or client specifications.

•        Production of study specifications for analysis datasets and pooled datasets for phase I-IV clinical trials.

•        Provide input as appropriate into specifications for data listings, data summaries/tables and figures for phase I-IV clinical trials, and for overall summaries of safety and efficacy, to ensure adherence to the standards of the company and/or its client.

•        Provide quality control for the above deliverables.

•        Produce SAS programs written to a standard as defined by the company and/or client good programming practice requirements.

•        Clearly document all work ensuring that program and project documentation are maintained to a high standard and on an ongoing basis.

•        Provide programming input into CRF(s) and data management plan(s) to ensure that these documents are consistent and adhere to the standards of the company and/or its client.

•        Provide input from a statistical programming perspective to the statistical analysis plan, the QC plan and project convention documents.

•        Provide input into specifications of data structures and databases to ensure adherence to company and/or client standards.

•        Adhere to pre-defined project/study standards and specifications.

•        Input for specific data types into the estimation of task durations for programming deliverables.

•        Maintain efficient interfaces with internal and external customers in consultation with management.

•        Perform role of programming lead on selected data types on studies.

•        Provide transfer of SAS derived datasets, outputs and programs (as appropriate) from company to Client.

•        Ensure project and resource tracking sheets are accurate and updated as required.

•        Maintain up-to-date knowledge of new developments/functionality of SAS as new versions are released.

•        Actively participate at meetings, discussions and activities covering statistical programming aspects for assigned trials.

•        Provide input to departmental processes and procedures and take part in process initiatives as required by management.

•        Act as a SAS programming consultant to internal customers for projects.

•        Induct and coach programmers as appropriate on technical, trial and project level processes.

•        Provide input to the appraisal process when required.

•        Provide input into recruitment process as required.

•        Ensure timesheets are accurate and updated on a weekly basis.

Experience/Qualifications required

Skills:

 •        Good SAS programming skills (BASE, MACRO, GRAPH).

•        Knowledge of clinical trial practices, procedures and methodologies.

•        Knowledge of statistical principles underlying clinical trials.

 
 Experience:

 •        Knowledge and experience in database design and structures.

•        Previous experience in programming in a clinical trials environment or in a related field.

 Qualifications:

 •        Minimum of BSc/BA or equivalent in computer science, mathematics, statistics, life sciences or related field(s).

 Contact:

For more information or to make an application, please contact Philip North at NorthWise Services, as follows:

Telephone: +44 (0) 1795 411 571

Email: philip.north@northwiseservices.com

SAS Programmer

Reference number: 1931 Apply for this job Apply for this job »
Type: Contract, full time Location: Aachen, Germany (nearest airports Cologne, Dusseld

Job Description

Summary:               

SAS programming support for a drug regulatory submission.

 The Role:                 

The successful candidate will provide SAS programming support for a drug regulatory submission which is to be made. The role will commence in September 2011 and will initially be for a period of 4 months, though there is the possibility that this could be extended. The successful candidate needs to be a skilled SAS programmer and will ideally have some statistical knowledge, gained from programming statistical summaries of data.

Experience/Qualifications required

Experience:              The successful candidate will have a few years’ experience of SAS programming within a pharmaceutical company or CRO environment and within a clinical trials context.

 Language:                 Whilst fluency in German would not be disadvantageous for this position, it is not essential, and fluency in English alone would suffice.

Statisticians

Last updated: 11:42 22/02/2013

Senior Biostatistician

Reference number: 2001 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex, office based

Job Description

Summary:

 The role of the Senior Biostatistician is to provide expert statistical input and consultancy to clinical Trials and clinical development projects including design of clinical trials, specification and production of analysis and reporting deliverables (including integrated summaries) on behalf of and/or in conjunction with the company’s clients.

 The Role:

  • Provides statistical consultancy for the design and analysis of clinical projects and/or studies
  • Performs sample size calculation based on clinical input/literature review with regards to expected treatment effects and variability estimates
  • Generates and manages randomisation schedule according to the requirements of the study design
  • Provides statistical input into and reviews clinical protocols and CRFs to ensure that both documents meet the requirements of the study including writing the statistical methodology section of the protocol
  • Provides input to the Data Management Validation Plan (DMVP) to ensure that data are collected and validated to provide high-quality data suitable for statistical analysis and reporting
  • Writes, reviews and manages the Statistical Analysis Plan (SAP) including detailed description of statistical methods planned for the analysis of data and table, listing and figure shells describing the planned statistical outputs. Chair analysis planning meetings with internal and external customers (as appropriate)
  • Reviews (and approves) the clinical database as appropriate for statistical analysis prior to database lock
  • Writes programs to perform inferential statistical analyses according to the requirements of the SAP; performs exploratory analysis as appropriate
  • Provides expert statistical input to Clinical Trials Reports and/or publications; writes the Statistical Methods section and reviews results, discussion and conclusion for appropriate statistical interpretation and inference of results
  • Files and archives all trial statistical documentation
  • Performs quality assurance of deliverables of other Biostatisticians within the department
  • Maintain professional and proactive interactions with internal and external customers
  • Maintain up-to-date knowledge on statistical techniques and procedures
  • Assist in the development of 'best-in-class' analysis and reporting processes
  • Responsible for the specification, programming and statistical reporting of integrated summaries
  • Generate cost estimates for statistical activities in response to client requests
  • Perform budget tracking for assigned trials

Experience/Qualifications required

Skills and Attributes:

 ·         Good organisational skills, plus an understanding of resource and budgeting

·         Good interpersonal and communication skills and the ability to operate effectively in a global working environment

·         Work calmly under pressure and meet deadlines

·         Professional, positive and enthusiastic attitude

·         A good understanding of medical terminology, clinical trial methodology, drug development process and ICH/GCP (especially relating to statistical methodology) 

·         A good investigative and meticulous approach to all activities and tasks

·         Transparent approach, clear and precise

·         Team player

·         The ability to delegate tasks

·         Assist improving the effectiveness of the organisation such as developing new processes, systems and client relations

·         Work effectively and efficiently with internal partners in the company

 Experience:

·         Knowledge/experience in SAS programming (or suitable equivalent data manipulation/statistical analysis software e.g SPSS).

·         Knowledge of global clinical trial practices, procedures, methodologies.

 Qualifications:

 ·         Minimum of a degree (B.Sc.) or equivalent in Medical Statistics or minimum of a degree (or equivalent) in Statistics/Mathematics in conjunction with at least one year’s experience in the application of statistics in clinical trials at a CRO, pharma company or academic institution.

Biostatistician

Reference number: 1992 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Office based in Basel, Switzerland

Job Description

Summary:

 Responsible for all statistical tasks for assigned clinical trials in the Oncology therapeutic area. This includes: protocol writing, analysis planning and reporting, exploratory analyses, publication support, and statistical consultation.

 Reports to Programme Statistician

 Reports to Group Head Biostatistics

 

The Role:

 Coordinate study tasks with other statisticians and statistical programmers.

 Ensure timeliness and adequate quality of all statistical deliverables.

 

  • Follow processes and adhere to the company standards and project standards as well as Health Authority requirements.

Experience/Qualifications required

Skills and Attributes:

 Strong statistical skills and knowledge of clinical trials methodology: experience with protocol development, analysis planning and reporting of clinical trials

 Knowledge of SAS

 Fluent in English, good oral and written communication skills

 Experience in oncology

 Good team player

 High degree of autonomy in performing assigned duties

 Able to establish personal relationships with personnel from other line functions

 Experience:

 At least 5 years experience in pharmaceutical development and clinical research

 Experience with intercultural teams

 

Qualifications:

 Minimum MSc in statistics

Statistician

Reference number: 1991 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Office based in London, UK

Job Description

Summary:

 To work as project/study statistician in multi-functional teams to provide statistical support on clinical trial design, analysis and report.

 Supervisory role in managing external service providers (CROs).

Reporting to Senior Manager of statistics in Data Sciences department.

 The Role:

 1   Works as project/study statistician in multi-functional project teams. Main responsibilities include:

 ·         Provides statistical input in study design, analysis and reporting.

·         Contributes to the development of study synopsis, protocol, (e)CRF design, study report and publications. Co-ordinates and contributes to the development of statistical analysis plan and statistical report. Performs or co-ordinates exploratory analysis as needed.  

  • Represents the statistics function in multifunctional project teams to ensure statistics-related activities conducted by the project teams and CROs are consistent with statistics SOPs, guidelines and standards.

 

2   Participates in the evaluation and selection of external vendors. Provides oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs from the study start-up through archiving. Reviews and validates statistics related CRO deliverables.

 

3   Contributes to the development and implementation of the internal/departmental standards and process improvements.

 

4   Commits to his/her own professional development by attending regular training and conferences, keeping up to date with the latest industry techniques and regulations.

 

5   Provides training to the company employees.

Experience/Qualifications required

Skills and Attributes:

 ·         Good understanding of clinical study designs, statistical inferences and commonly used statistical methodologies.

·         Good knowledge of EMEA/FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.

·         Comprehensive knowledge of the pharmaceutical industry including understanding of clinical drug development process and GCP requirements.

·         Good skill of statistical programming languages including SAS.

 

·         Good project management skills

·         Excellent communication skills and ability to work with cross-functional teams

·         Excellent knowledge of clinical quality standards

 

 

Experience:

 

Ideally 3-5 years of demonstrated experience as a statistician within a Pharmaceutical company, a Biotech or a CRO.

 

 

Qualifications:

 

An Msc or a PhD or equivalent in biostatistics, statistics or mathematics.

 

Statistician

Reference number: 1990 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based in London, UK

Job Description

Summary:

 To work as project/study statistician in multi-functional teams to provide statistical support on clinical trial design, analysis and report.

 Supervisory role in managing external service providers (CROs).

Reporting to Senior Manager of statistics in Data Sciences department.

 The Role:

 1   Works as project/study statistician in multi-functional project teams. Main responsibilities include:

 ·         Provides statistical input in study design, analysis and reporting.

·         Contributes to the development of study synopsis, protocol, (e)CRF design, study report and publications. Co-ordinates and contributes to the development of statistical analysis plan and statistical report. Performs or co-ordinates exploratory analysis as needed.  

  • Represents the statistics function in multifunctional project teams to ensure statistics-related activities conducted by the project teams and CROs are consistent with statistics SOPs, guidelines and standards.

 2   Participates in the evaluation and selection of external vendors. Provides oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs from the study start-up through archiving. Reviews and validates statistics related CRO deliverables.

 3   Contributes to the development and implementation of the internal/departmental standards and process improvements.

 4   Commits to his/her own professional development by attending regular training and conferences, keeping up to date with the latest industry techniques and regulations.

 5   Provides training to the company employees.

Experience/Qualifications required

Skills and Attributes:

 ·         Good understanding of clinical study designs, statistical inferences and commonly used statistical methodologies.

·         Good knowledge of EMEA/FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.

·         Comprehensive knowledge of the pharmaceutical industry including understanding of clinical drug development process and GCP requirements.

·         Good skill of statistical programming languages including SAS.

 ·         Good project management skills

·         Excellent communication skills and ability to work with cross-functional teams

·         Excellent knowledge of clinical quality standards

 

Experience:

 Ideally 3-5 years of demonstrated experience as a statistician within a Pharmaceutical company, a Biotech or a CRO.

 
 Qualifications:

 An Msc or a PhD or equivalent in biostatistics, statistics or mathematics.

 

 

(Senior) Statistician

Reference number: 1977 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Basel Switzerland

Job Description

Therapeutic Area:   Oncology

 The Role:

 The successful candidate will be responsible for the following duties:

  • Responsible for all statistical tasks on the assigned clinical trials: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses, and additional analysis to support publications.
  • Provide statistical consultation to clinical team and support decision making process by providing adequate information.
  • Track clinical trial/allocated project activities and milestones.
  • Ensure timeliness and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials.
  • Follow processes and adhere to company and project specific standards as well as Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regulatory guidelines).
  • Participate in or lead non-clinical project activities as needed.
  • Application and extension of existing Bayesian methods for dose finding and proof of concept
  • Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and B&SR team.

 

Experience/Qualifications required

Skills and Attributes:

 Knowledge and expertise in Statistics, in particular the use of applied Bayesian statistics in decision making.

  • Knowledge of statistical software packages (e.g. WinBUGS, R, SAS)
  • Communicate efficiently with non-statistician colleagues.
  • Able to work with a multidisciplinary team to achieve team’s objective.

 Language Skills:

 Fluent English (oral and written).

 Qualifications:

 Masters Degree in Statistics (or equivalent degree) with at least 2 years of experience or PhD in Statistics (no previous experience is required).

Health Outcomes Statistician

Reference number: 1970 Apply for this job Apply for this job »
Type: Permanent, full time Location: Manchester, UK

Job Description

 The Role:

 Our client is a highly respected International Consultancy in the fields of Health Economics, Market Access and Patient Reported Outcomes which helps its clients bring healthcare products and services to the market successfully by investigating and developing scientific evidence to understand the benefit to patients, clarifying and communicating the value for decision-makers.

 Due to continued growth our client is seeking an experienced statistician with experience in Health Outcomes Research.

 To further develop our client’s analytical and consulting activities in clinical outcomes assessments, we are looking for a senior statistician with a strong background in Outcomes Research, in particular in longitudinal and cross-sectional modelling.

 This is a leadership position in which the successful candidate will advise clients on their outcomes strategy, endpoint development, validation, analysis, and interpretation.

 The Health Outcomes Statistician will also direct project teams for analytical work and lead FDA submissions.

 In return our client offers excellent remuneration, pension contributions, and a sports subscription, together with support for further qualifications, in a friendly and informal

Experience/Qualifications required

Qualifications:

 PhD or Masters degree (or equivalent) in Psychometrics, Biostatistics, Statistics, Epidemiology or Mathematics with significant experience in outcomes research

Biostatistician II

Reference number: 1954 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Uxbridge

Job Description

Summary:

 Our client is a top international CRO which is seeking an experienced Biostatistician ideally in its Uxbridge office but our client could also consider its Sheffield office.

 The Biostatistics and Statistical Programming Department is involved in a wide range of therapeutic areas and as part of this group, you will work within a challenging environment, with exposure to many different clients, indications, and compounds.

 The Biostatistician works independently in the programming and quality control of derived datasets and all kinds of statistical outputs (e.g., tables, listings and figures), works under the supervision of an experienced biostatistician in the production of analysis plans and reports, provides basic statistical advice to clients and fulfils the project primary role within a designated project team.

 The Role:

 Key Accountabilities:

 Production and/or QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniques

 Understand and apply moderately advanced statistical methods

 Coordinate and lead a project team to successful completion of a project within given timelines and budget

 Interact with clients as key contact with regard to statistical and contractual issues

 Assist in the production of analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents

 Check own work in an ongoing way to ensure first-time quality

 Provide training in statistical analysis to internal clients

 Proactively participate in and/or lead process/quality improvement initiatives

 Mentor and train junior members of the department

 Support of Business Development, e.g. by attending and preparing bid defence meetings

 Travel, attend and actively contribute to all kinds of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)

 Additional responsibilities as defined by the supervisor/manager.

Experience/Qualifications required

Skills and Attributes:

 - Good analytical skills

 - Good Project Management skills

 - Professional attitude

 - Attention to Detail

 - A good understanding of statistical issues in clinical trials

 - Ability to work independently

 - Good mentoring/ leadership skills

 - Competent in written and oral English.

 Experience:

 - Prior experience with SAS Programming required

 Qualifications:

 - PhD or equivalent in Statistics or related discipline entry level, MSc in Statistics or related discipline with biostatistics experience in a clinical trials environment.

 

Senior Biostatistician

Reference number: 1953 Apply for this job Apply for this job »
Type: Permanent, full time Location: Uxbridge or Sheffield

Job Description

Summary:

 Our client is a top international CRO which is seeking an experienced Senior Biostatistician ideally in its Uxbridge office but our client could also consider its Sheffield office.

 As Senior Biostatistician you will lead the production and quality control of all kinds of statistical deliverables including analysis plans and reports. You will work closely with clients to provide hands-on statistical advice, from study design to discussion of analysis results, whilst fulfilling the project primary role within the project team. You will collaborate with Medical Writing, Data Management, and other departments in order to provide a comprehensive and professional service to the clients.

 The Role:

 The Senior Biostatistician is fully responsible for the end-to-end delivery of the assigned project, from both an internal and external perspective. This will include the following responsibilities:

 - Coordinate and lead a project team to successful completion of a study project

 - Interact with clients as key contact regarding all statistical and contractual matters

 - Lead production and quality control of randomisations, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process-supporting documents

 - Perform QC of derived datasets and all kinds of statistical deliverables produced by other members of the department

 - Support and actively contribute to the development of client proposal documents

 - Represent at client marketing and technical meetings, both local and international

 - Proactively participate in and/or lead process/quality improvement initiatives

 - Mentor and train junior members of the department.

Experience/Qualifications required

Skills and Attributes:

 - Thorough understanding of statistical issues in clinical studies (interventional and non-interventional)

 - Excellent analytical skills and strong attention to detail

 - Ability to work independently

 - Business awareness / business development skills.

 Experience:

 This role requires a combination of statistical expertise, project management ability and excellent communication skills. We are therefore looking for someone with a strong statistical background in Clinical Research, who can really drive their project forward whilst fulfilling a pivotal role between the client and the project team. The ability to represent the company to clients is greatly desired; you will have experience in discussing complicated data in an easy to understand format while presenting a highly professional personal and corporate impression.

 In addition you will need:

 - Experience in statistical analysis in a clinically related subject, for example (Pharmaco-)Epidemiology, either academically or professionally, Outcomes Research or Health Economics

- Practical experience with SAS programming

 Qualifications:

 - Graduate or equivalent degree in Biostatistics, or Epidemiology/Pharmacoepidemiology.

Associate Director Biostatistics

Reference number: 1951 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sheffield or Uxbridge

Job Description

Summary:

 Our client is a highly respected CRO which is seeking an Associate Director of Biostatistics ideally in either its Sheffield or Uxbridge offices.

 The Associate Director contributes to and leads strategic initiatives for the structure and development of the Biostatistics department in order to achieve the overall goals and mission of the company.

 The Associate Director is responsible for managing teams of statisticians involved in the production of clinical trial reports and in the provision of statistical services.

Key Accountability:

 Identify strategic needs within the Biostatistics Department

 Develop and successfully implement a plan for specific strategic initiatives

 Represent the Biostatistics Department in high-level internal initiatives

 Represent the company at client marketing and technical meetings

 Business development and the identification of new business opportunities

 Maintain and monitor budgets for non-billable spending

 Manage the recruitment process for new Biostatistics team members

 Resource planning

 Evaluate and resolve complex personnel issues

 Implement disciplinary procedures if required

 Coordinate development of client proposal documents

 Resolve client problems as and when they arise

 Consult with clients on technical, statistical or regulatory issues, as appropriate

 Provide support to Functional Lead in terms of changes in scope and contractual issues

 Provide internal technical support to the Biostatistics Department

 Develop agendas and chair departmental meetings

 Lead the development of new SOPs and guidelines as needed

 Identify the need for process and quality improvement initiatives

 Check own work in an ongoing way to ensure first time quality

Experience/Qualifications required

Skills and Attributes:

 - Financial knowledge, able to read a Profit and Loss (P&L) summary and present financial information

 - Strategic awareness of our business environment

 - Detailed awareness of the activities of other groups within the company

 - Advanced people management and leadership skills

 - Able to work with senior managers on strategic initiatives

 - Highly professional attitude

 - Attention to detail

 - Excellent analytical skills

 - Able to work under pressure and motivate others

 - Thorough understanding of statistical issues in clinical trials

 - Excellent knowledge of all statistical and reporting processes within the Biostatistics department

 - Good communication skills essential

 Qualifications:

 - Minimum of first degree (undergraduate or equivalent) in Biostatistics or another relevant discipline

Contract Biostatistician/Senior Biostatistician

Reference number: 1947 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Sussex

Job Description

Summary:

 Our client is seeking a contract Biostatistician to be based in its offices in West Sussex.

 Core Responsibilities:

The provision of expert statistical input and consultancy to Phase 1-4 global clinical trials including design of clinical trials and production of analysis and reporting deliverables on behalf of and/or in conjunction with clients.

 Principal Accountabilities:

•Provide input as appropriate into all meetings, discussions and activities covering all statistical aspects for assigned trials.

•Provide statistical input (as appropriate) into study protocol and CRF to ensure that both documents meet the requirements of the study and of client(s). Ensure adherence to standards (client and/or company), relevant regulatory guidelines and the provision of good statistical practice.

•Generate and review randomisation lists and code-break envelopes in accordance with company and/or client procedures.

•Provide statistical input to the Data Management Validation Plan to ensure delivery of appropriate high quality clinical data suitable for statistical analysis and reporting.

•Author and/or provide input to trial Statistical Analysis Plans. Write detailed statistical methods according to the requirements of the protocol. Prepare table, listing and figure shells in conjunction with the Statistical Programmer(s). Chair analysis planning meetings with internal and external customers (as appropriate).

•Perform ongoing review of clinical data from company/client databases to identify potential issues with data impacting the statistical analysis.

•Program and conduct statistical analyses and provide high-quality statistical output for inclusion in clinical trial reports.

•Provide expert statistical input to clinical trial reports (as appropriate). Write statistical methods section and review results and conclusions for appropriate statistical interpretation of results.

•Responsible for quality control of all statistical analysis deliverables and quality assurance of programming deliverables provided by the company's Statistical Programmer(s) for assigned trials.

•Maintain professional and proactive interactions with internal and external customers.

•Maintain up-to-date knowledge on statistical techniques and procedures by attendance at professional courses and conferences and by ongoing review of statistical literature.

•Review the clinical database for acceptance for statistical analysis prior to database lock (as appropriate)

•Ensure maintenance and appropriate filing of trial statistical documentation for delivery to clients.

•Assist in the development of ‘best-in-class’ analysis and reporting processes to ensure operational efficiency of Biostatistics’ function.

•Support Senior Biostatisticians in the production of expert statistical input to clinical development programmes, ISS, ISE and other forms of integrated statistical analyses.

Experience/Qualifications required

Skills:

 •Knowledge/experience in SAS programming (or suitable equivalent data manipulation/statistical analysis software e.g SPSS).

•Knowledge of global clinical trial practices, procedures, methodologies.

 Experience:

 •Experience in the application of statistics in clinical trials at a CRO, pharmaceutical company or academic institution.

 

Qualifications:

 •Degree (BSc) or equivalent in Medical Statistics or Statistics/Mathematics

 Contact:

For more information or to make an application, please contact Philip North at NorthWise Services, as follows:

Telephone: +44 (0) 1795 411 571

Email: philip.north@northwiseservices.com

Senior/Principal Biostatistician

Reference number: 1945 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex

Job Description

Summary:

Our client is seeking an ambitious individual to join its growing Biostatistics group based in West Sussex to contribute to its statistical design, analysis and reporting services. This position can also be partly home based.

The company provides a complete statistical service, including statistical input to study design, protocol development, consultancy, planning, specifying and performing statistical analyses, conducting their write-up, and collaboration in the production of integrated study reports.

 The Role:

 You would be involved in all of the above areas, and would be responsible for statistical aspects of projects which could range in size from small early phase I trials to larger, later phase II-IV trials across a comprehensive range of therapeutic areas. In the role you would provide input to study protocols, program and conduct statistical analyses providing high quality "report ready" statistical output and critically review results and conclusions to ensure their valid and correct interpretation.

 Further, you would develop key documents, including the Statistical Analysis Plan, Quality Control and Project Conventions Plans and, working closely with the Statistical Programmers, review the derived data set specifications and trial safety data tables, listings and figures they produce. You would also be responsible for providing the statistical input into parts of the Data Management process including reviewing the eCRF (or CRF) database structure and data cleaning strategies.

Experience/Qualifications required

Skills:

 The company is looking for dynamic professionals with a depth of statistical understanding and associated clinical trials experience, as well as a sound knowledge of SAS. You will also need to be pro-active with a proven ability to work in multidisciplinary teams to agreed timelines and, most importantly, to be able to communicate effectively to both statisticians and non-statisticians alike.

  Experience:

 Minimum 3 years experience.

Proven home-based experience if partly home-based.

Relevant experience in the area of the design and analysis of clinical trials. Experience of the design and analysis of oncology studies would be desirable although not essential.

 Qualifications:

 You will have a BSc and/or an MSc in Statistics (or equivalent).

 

Contact:

For more information or to make an application, please contact Philip North at NorthWise Services, as follows:

Telephone: +44 (0) 1795 411 571


Senior Biostatistician

Reference number: 1923 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sussex

Job Description

Job Description:

Our client is seeking an ambitious individual to join their growing Biostatistics group based in West Sussex to contribute to their statistical design, analysis and reporting services. This position can also be home based.

 The company provides a complete statistical service including statistical input to study design, protocol development, consultancy, planning, specifying and performing statistical analyses, conducting their write-up, and collaboration in the production of integrated study reports.

 You would be involved in all of the above areas, and would be responsible for statistical aspects of projects which could range in size from small early phase I trials to larger later phase II-IV trials across a comprehensive range of therapeutic areas. In the role you would provide input to study protocols, program and conduct statistical analyses providing high quality "report ready" statistical output and critically review results and conclusions to ensure their valid and correct interpretation.

 Further, you would develop key documents including the Statistical Analysis Plan, Quality Control and Project Conventions Plans, and, working closely with our Statistical Programmers review the derived data set specifications and trial safety data tables, listings and figures they produce. You would also be responsible for providing the statistical input into parts of the Data Management process including reviewing the eCRF (or CRF), database structure and data cleaning strategies.

Experience/Qualifications required

Candidate Requirements:

The company are looking for dynamic, professionals with a depth of statistical understanding and associated clinical trials experience, as well as a sound knowledge of SAS. You will also need to be pro-active with a proven ability to work in multidisciplinary teams to agreed timelines, and most importantly, to be able to communicate effectively to both Statisticians and Non-Statisticians alike.

 

You will have a BSc and/or an MSc in Statistics (or equivalent) and have demonstrated relevant experience in the area of the design and analysis of clinical trials. Experience of the design and analysis of Oncology studies would be desirable although not essential.

 In return, the company provides excellent training, personal development, career opportunities, international placements and a competitive package of salary, pension, private healthcare and other benefits.

 

This is a permanent position.

Senior Director, Global Biostatistics

Reference number: 1922 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sussex

Job Description

Job Description:

Our client is looking for a Senior Director, Global Biostatistics to lead the strategic direction of their biostatistics department.

The Senior Director will manage teams and outputs over our clients four offices based in both Europe and the US.

The successful applicant will support business development activity, manage projects and liaise with partners and clients.

Experience/Qualifications required

Candidate Requirements:

The ideal candidate will have a degree in life sciences, maths or statistics or equivalent and have considerable experience in biostatistics in a global clinical research environment.

Strong leadership and communication skills are a must.

 This is a permanent position based in Sussex.