NorthWise Recruitment™

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

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. 

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

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.

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.

Job Description

 Summary:      Monitor assigned to investigative sites to ensure subject safety and timely, high-quality data in compliance with study protocol, ICH, GCP and local regulations.

REPORTS TO:

Country Clinical Monitoring Manager or Country Clinical Monitoring Specialist.

The Role:

 Responsibilities include, but are not limited to:

Investigative site management and monitoring

Demonstrate commitment to quality in all aspects of monitoring; ensure ethical conduct of clinical studies; adhere to study monitoring instructions/conventions, write reports within the timeframe agreed at study start, conduct Feasibility assessment, Pre-study Visit, Site Initiation Visit, Monitoring Visits and Close-Out visit at investigative sites; regular review of Investigator Site Files; ensure proper

handling of IMP; ensure site inspection readiness; ensure site performance (recruitment) as planned;

Monitor and track the informed consent process

Ensure data integrity

Conduct Source Document Verification of CRF data against medical records/pharmacy records, etc. to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with Clinical Development Data Management in order to improve data quality; ensure issues relating to data quality are escalated and resolved with the study team

Monitor subject safety

Perform safety reviews/SAE reconciliation and assure appropriate action is taken at the investigative site in accordance with the appropriate policies and SOPs, as well as ICH-GCP guidelines and local regulations

Experience/Qualifications required

Knowledge, Skills and Experience:

 · Minimum of 2-3 years' monitoring experience or combination of monitoring and other clinical research relevant experience

· Knowledge of the Clinical Development process

· Proven track record of demonstrating thorough knowledge and application of ICH GCP and applicable local regulations

· Proficient knowledge of regional healthcare environment

· Experience in Investigator contract management, if applicable for region

· Experience in preparing documents for submission to IRBs/IECs and Competent Authorities, if applicable for region

· Computer literacy (e.g. EDC, CTMS, MS Office, etc.)

· Excellent verbal and written communication skills in English and other language(s) as

appropriate for country

Preferred

· Experience in participating in internal audits

For Senior CRA level

· Minimum of 5 years' CRA experience or combination of CRA and other clinical research relevant experience

· Previous involvement in protocol, CRF, or other trial-related development activities

Attributes:

· Highly self-motivated and proactive, with a keen attention to detail

· Goal oriented, able to effectively prioritise and execute tasks in a high-pressure environment environment

· Excellent written and oral communication skills, including presentations

· Strong interpersonal skills, excellent relationship-building and negotiation skills

· Ability to work independently

· Strong problem-solving skills

· Ability to resolve routine issues effectively and independently

· Excellent organisational and time management skills as well as working flexibility

· Willing and able to travel

 Qualifications:

 · University degree in Biological Science/Pharmacy/Nursing or qualification in Nursing

 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

Job Description

Summary:

 To provide clerical/administrative operational archive services to Clinical.

Delivery of services needs to be on CLIENT site.

 The Role:

 ACCOUNTABILITY:

 ·         Performs all tasks in accordance with appropriate regulatory/legal requirements and approved CRM procedures and best practices.

·         Conducts quality control checks on documents received.

·         Ensure records received can be reconciled with archive deposit form.

·         Carries out all duties with due regard to Health and Safety and security standards.

·         Responds to customer requests via email, phone or walk-in.

·         Performs categorisation (sorting in order to maintain easily tracked ‘warehouse’ of incoming materials) and data entry of incoming archive materials where necessary.

·         Archives physical records within the local archive facility.

·         Fulfils and records information requests in the most appropriate and secure medium.  Examples include loans of archived materials, including biological specimens, and preparation of photocopies or image files as appropriate.

·         Maintains records of access to original documents to ensure return of materials loaned from the archive.

·         Regularly checks temperature and humidity chart recorders, according to approved CRM procedures.

·         Accountability for interacting with 3rd party contractors to ensure secure, accurate hand-off/transfer of materials.

·         Attend relevant job training (including relevant safety training) as determined by CLIENT.

·         Ensure training records are current as per CLIENT policies.

Experience/Qualifications required

          Works within set guidelines and under close supervision.

·         Follows set processes and procedures with no latitude for changing or amending (suggestions for improvements are encouraged).

·         Escalates client issues to clinical archivist or their designees for resolution.

·         Builds and maintains productive working relationships with team members.

·         Good physical fitness is required.  The job involves manual handling of storage boxes and use of step ladders.

 
 Knowledge:

 ·         Possesses knowledge related to immediate work area, work routines, practices and procedures.

·         Demonstrates good attention to detail.

·         Demonstrates basic competency in CLIENT desktop computing tools e.g. Outlook, Excel, Word and other office machinery as appropriate.

·         Demonstrates courteous, professional, and assertive communication skills – on the telephone, face-to-face and in writing.

·         Demonstrates ability to advise / educate Clinical clients on basic archiving requirements (for example, the use of archive deposit form, simple searching, submission and use of electronic content, restrictions on loans of original materials, etc.)

·         Can work both in English and French, very good verbal and written skills

Experience:

 ·         Experience in the pharmaceutical sector

 Qualifications:

 ·         Very good written and spoken French and English

·         Experience/degree in archiving or documentation strongly appreciated

Job Description

Summary:

 Complexity:

• Processes and procedures involving both muldi-disciplinary (Medical, Biostatistics, Sciences Writing, Data Management, Study Coordination, monitoring, External Lab Coordinators, CTSU, CIPLA, Procurement, Clinical Finance, Global Resourcing & Benchmarking, regulatory, Project Management,…) and geographically remote partners on a project level. The clinical development of the projects may contain up and above 50 different studies (ongoing, planned,…).
• Exercise leadership in a non-hierarchical context, need to negotiate and influence at different levels of the organisation.
• Influence clinical programme and study strategies yielding robust predictable plans. 
• Establish network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in project delivery.
• Within Core Team, makes routine and complex decisions in order to maximise the successful design and delivery of the clinical development plan.

• Key Responsibilities

  ·         Responsible for developing detailed and realistic fully –loaded budget ($ and resources) and timelines plans (including alternative scenario,…).  Project budget potential to approximately $50-100 Million per year for big projects (e.g. Flu, Cervarix, Malaria…). Monitoring and managing project spending and resource needs.

  ·         Accountable for reporting on project progress (timing, budget, resource needs, quality, action plans,….), for pro-actively highlighting risks & potential issues, and for proposing solutions/ensuring resolution plans are implemented on a timely manner.

  ·         Acts as a central point of contact for knowledge of overall operational clinical projects status and issues (at central and regional levels) and for issue escalation to Senior Management (GCDC Heads, GCRD Head,…)..

  ·         Within his/her area of expertise, is accountable for developing and delivering the clinical development plan in realistic time, with the most effective use of resources and adequate level of quality, in order to deliver and maintain a product of global value.

   Accountability:

   1.    Milestones and timing :

  ·         Accountable for consistently achieving high standards in attainment of project timelines in global projects.

  ·         Defines the clinical project in terms of milestones, i.e. proposes timing to Clinical Development Manager (CDM, MD)/Lead CDM by incorporating input from Clinical Operations (both central and regional) in terms of (1) Timing feasibility, (2) Resources and (3) Training.

  ·         Creates and keeps clinical project plans updated and communicates global clinical project timelines in a cohesive manner through monthly meetings.

  ·         Ensures that all parties are informed of the status of activities, flags delivery progress impediments and, in collaboration with relevant team members, reports on clinical project progress/issues.

  ·         Informs if changes in timing are needed, discusses with regions/clinical operations functions in order to update the overall clinical project plan

  2.  Resource allocation

  ·         Actively manages in study allocation process (in collaboration with Lead CDM/CDM).

  ·         Integrate the resources needs across project, interface with the functional lines and proactively flag resource bottlenecks in the clinical project team.

  ·         Negotiate/agree on adequate staffing levels with functions and regions, resolve resources issues with function heads.

  ·         Highlights deviation from agreed clinical plans in case of delays and risk that critical milestone (e.g. BMT milestones, Post Approval Regulatory Commitment) is not reached.

  3.  Budget

  ·         Tracks project budget related to investigators fees taking into account forecast from CDM/Lead CDM.

  ·         Tracks and solves deviations

  ·         Tracks other clinical project budget utilisation, country/region resources allocation and highlights deviation from agreed budget with countries, regions and clinical operations functions

  ·         Maintains information update in SAP

  ·         Challenge and negotiate study budget with countries (in collaboration with Finance/Clinical Finance and Procurement)

  4.  Problem solving

  ·         In collaboration with Lead CDM/CDM, solves operational clinical project related problems, unlocks bottlenecks, and generally clarifies confusion by involving appropriate individuals when issues arise, gathering information and communicating in a consistent manner. Takes actions to draw team to problem resolution and ensures compliance, timely completion of milestones and respect of budget/resource.

  ·         Has to solve problems at regional level (negotiate with regional head or country medical Director) and at clinical operations functions level (both at central and regional level).

  ·         Directly interact with Senior Management (e.g. GCDC Heads, Head GCRD, ….) on project status, issue escalation and recommendations.

  5.  CDP and protocol input

  ·         Supports Lead CDM/CDM through CDP preparation, critically evaluate and challenge the CDP design in terms of content, clinical project timing, budget and feasibility

  ·         Develops full-loaded cost budget for the CDP; participate to budget and resource calculations for portfolio analysis.

  ·         Present full project plan (budget, resources, timelines) during Joint CDP review meeting with GCDC Heads and Functional Heads.

  6.  KPIs

  ·         Follows clinical project related KPIs, identifies issues and draws attention to solve them

  7.  Tools and Key Lessons Learned (KLL)

  ·         Ensures progress and information circulation/sharing tools are developed in a harmonised manner through the clinical project

  ·         Communicates overview of all key lessons learned (KLL) at clinical project level to CPT and at CPM Head level

  ·         Shares best practices with other CPMs and with Central and Regional Operations

  8.  Meeting

  ·         Organises and leads Clinical Project Team (CPT), with a spirit of creativity and instills optimism and can-do attitude.

  ·         Prepare and present (together with L-CDM) a project update at the monthly project review meeting with HCDC Head.

  ·         Prepare the quarterly project updates for Upper Management GCDC Heads, GCRD Head,…).

  ·         Actively participates in a variety of meetings if his/her presence is required (e.g. Project Team, Logistics, etc)

  ·         Ensure that effective meetings management practices (e.g. agendas, minutes, actions and agreements) are adopted for assigned CPTs

  9.  People Management

  ·         Provides formal feedback, which encourages team members to develop their skills. Provides performance feedback on matrix team members to the responsible line managers.

  ·         Coaches clinical project team members on project management skills.

  ·         Delegate tasks to the most appropriate person (e.g. CPM Assistant, Financial Analyst Manager,…) to make most appropriate use of resource and skills.

  ·         Evaluates training requirements within the project in collaboration with function heads.

   

Experience/Qualifications required

Experience:

 ¨       At least 5-7 years experience in clinical study conduct

¨       Experience in a matrix/complex/multi-disciplinary environment

¨       Proven record of successful project management

¨       Managerial experience to motivate and develop individuals and teams

 Qualifications:

 ¨       Masters degree in sciences (Life Sciences preferably) 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

Email: philip.north@northwiseservices.com

Job Description

Summary:                 The responsibility of the Senior Clinical Research Associate is to take a leadership role in overseeing the conduct of a clinical trial to insure the quality and integrity of data and safe and proper management of study parameters.

 The Role:                   In co-ordination with team members, the Senior CRA will exercise a leadership role for project activities related to monitoring functions by interfacing with clinical investigators and other site personnel in order to carry out this responsibility.

The Senior CRA will have the ability to work independently without constant monitoring and make judgments and decisions within project assignments.

Experience/Qualifications required

Experience:              Candidates should be able to offer industry experience gained within either a pharmaceutical company or a CRO as a Clinical Research Associate 2 or Senior CRA.

 Skills:                         Skills of value include excellent written and oral communication skills, ability to complete tasks in an accurate and timely manner and a flair for effectively managing multiple tasks. Candidates will also have a high level of presentation skills and an ability to take initiative and work independently.

 Qualifications:          A degree in a life science, nursing qualification or additional relevant experience.

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.

Experience/Qualifications required

Experience:              Solid previous CRA experience in clinical research.

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 detail.

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

Job Description

We are assisting a top CRO in finding contract CRAII's/Senior CRA's to be office based in Middlesex for a 6 month contract.

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

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.

Experience/Qualifications required

Applications are invited from candidates closely matching the following brief:

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

 Solid previous CRA experience in clinical research.

 Excellent interpersonal, verbal, and written communication skills.

 Client focused approach to work.

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

Job Description

We are assisting this globally recognised CRO in their quest to recruit a level II Clinical Research Associate to be office based in Middlesex or field based.

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

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.

Experience/Qualifications required

Applications are invited from candidates closely matching the following brief:

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

 Solid previous CRA experience in clinical research.

 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 detail.

Competetive Salary

Job Description

We are working with this internationally recognised and leading CRO to source an experienced CRA to perform the Senior CRA role within their Middlesex office or field based.

 The responsibility of the Senior Clinical Research Associate is to take a leadership role in overseeing the conduct of a clinical trial to insure the quality and integrity of data and safe and proper management of study parameters.

In coordination with team members, the Senior CRA will exercise a leadership role for project activities related to monitoring functions by interfacing with clinical investigators and other site personnel in order to carry out this responsibility.

The Senior CRA will have the ability to work independently without constant monitoring and make judgments and decisions within project assignments.

Experience/Qualifications required

Candidates should be able to offer industry experience gained within either a Pharma or CRO as a Clinical Research Associate 2 or Senior CRA.

 This should be further supported by a degree in a life science, nursing qualification or additional relevant experience.

 Additional skills of value include excellent written and oral communication skills, ability to complete tasks in an accurate and timely manner and a flair for effectively managing multiple tasks.  Candidates will also have a high level of presentation skills and an ability to take initiative and work independently.

Job Description

Job Purpose:

The Project Manager will have primary responsibility for the delivery of Clinical Projects and will be the main point of liaison within GFA for the client and associated third-part vendors. The Project Manager will also work with other client staff to develop and promote the business.

Main accountabilities:

Strategic

•

Maintain an awareness of, and provide feedback on, client, industry and regulatory developments to input into the strategic development of the department.

Operational

-Ensure study deliverables are achieved in a timely manner to agreed quality standards.

-Ensure all statutory reporting requirements are performed in line with local regulatory and ethics requirements.

-Review Sponsor contracts on a regular basis; ensure they remain current and in-scope. Escalate out-of-scopes to instigate change order process.

-Monitor / review project invoices.

-Management of study monitoring team; provide mentoring / training; participate in monitoring / co-monitoring of sites as appropriate

-Management of study documentation including: set-up and maintenance of the Trial Master File, study-specific forms, Investigator Site files, Ethics Committee submissions and archiving processes.

-Organisation and planning of study-related meetings; ensure written records are kept including all key decisions

-Review / preparation of draft study documents and reports

-management of the reporting of adverse events, as appropriate

-Assist with the provision of internal and external training courses, including preparation of materials and attendance at conferences and exhibitions

-Assist with development of the Clinical group’s infrastructure including review / preparation of Standard Operating Procedures

Main accountabilities:

Customer facing

Develop and maintain effective working relationships with internal and external clients, third parties and suppliers.

Maintain high levels of customer service to meet client expectations at all times.

Estimated time allocation

Strategic: 10%

Operational: 60%

Management: 0

Customer facing: 30%

Experience/Qualifications required

Essential Skills:

VALUES Behaviours

Commercial / Finance awareness – Level 1

•Communication – Level 2

•Persuading and Influencing – Level 1

•Organisation and Planning – Level 2

•Analytical Skills – Level 2

•Problem Solving and Decision Making – Level 2

•Developing others – Level 1

Technical/Specialist

•

Clinical Research Professional

Desirable Skills:

•Competent IT skills including the use of MS Office applications Word, Excel, Powerpoint and Outlook

Work Experience & knowledge:

•Experience from working in a pharmaceutical/healthcare product development environment.

•Previous experience as a CRA / Senior CRA is desirable.

•An overall understanding of drug development and the Clinical Trial process

Education level:

BSc

Degree required:

Part of what makes this client successful is the highly motivated people who work here and their enthusiasm for what we do and stand for! We recruit individuals whose passion, drive, integrity, initiative and customer orientation shines through. An inspiration to your colleagues and your team, you are a motivated individual who can instil trust and confidence in customer relationships whilst having a natural aptitude for getting the best out of people. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do. All employees at this client have certain shared responsibilities and these include:

-

to maintain and promote the reputation of this client as an ethical and expert consultancy company

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to maintain the confidentiality of patient, client and company information

-

to maintain good professional relationships with all external parties in contact with this client, including clients, suppliers, consultants and clinical trial investigators

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to maintain good working relationships with colleagues and to enable a team spirit within the company

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to contribute ideas on matters affecting the running of the company

to maintain an awareness of the business of the company and of all ongoing projects

to be organised in the planning of personal workload

to ensure that person development is maintained through continuous training assessment

to maintain technical expertise as appropriate

-to be conversant with the clients Standard Operating Procedures

Job Description

We have a new vacancy for a Clinical Research Associate, they need to have at least 1 year’s experience of GCP monitoring in the UK, experience from working in a pharmaceutical/healthcare product development environment and a good overall understanding of drug development and the clinical trial process

Experience/Qualifications required

The Clinical Research Associate will be responsible for monitoring clinical trial sites to ensure compliance with the protocol, with GCP and with other appropriate regulations and guidelines. The CRA will be the primary contact-point for Investigational Site staff.

Main accountabilities:

Strategic

Maintain an awareness of, and provide feedback on, client, industry and regulatory developments to input into the strategic development of the department.

Operational

monitoring of clinical study sites as appropriate, including pre-study, initiation, monitoring and close-down meetings with clinical study investigators

identification of clinical investigators

management of the Trial Master File for clinical studies as per GCP

management of the creation and maintenance of study-specific forms

management of the creation of Investigator Site files

management of the collation and copying of documents for Ethics Committee submissions

management of the archiving of study documents at the close of a project

organisation and planning of study-related meetings

handling of telephone and other enquiries from study site staff and clients during a study, as appropriate

management of the reporting of adverse events, as appropriate

Management

N/A

Main accountabilities:

Customer facing

Develop and maintain effective working relationships with internal and external clients, third parties and suppliers.

Maintain high levels of customer service to meet client expectations at all times.

Estimated time allocation

Strategic: 5%

Operational: 85%

Management: 0

Customer facing: 10%

Job Description

Our client offers a competitive employment package which includes health care cover, pension, death in service cover and relocation and additionally Child Care Vouchers and membership of its Sports and Social Club.                  

 Background:

 Our client is one of the largest specialist biometrics CROs in Europe. It is widely recognised as providing a service of the highest quality to the global pharmaceutical and biotechnology industries.

 
 The Role:

 You will be expected to contribute significantly to the Electronic Data Capture (EDC) and project management aspects of Data Management, including management, development and review of EDC databases, both from an internal and external vendor perspective. In addition, you will be the Data Management lead on a number of projects, having the ability to work as part of the project team as well as on your own initiative.

 You will be required to represent our client at both internal and external project meetings with its clients and will require a detailed understanding of client processes and trial designs. 

Experience/Qualifications required

Skills:

 The successful candidate must have a flexible approach to his/her work, be self-motivated, have excellent organisational skills and be able to motivate and direct others within a project team environment.  Good problem solving and decision making skills are essential, as is the ability to help facilitate the development of EDC Data Management skills in Data Managers and Data Associates.

 Experience:

 You will have preferably implemented and worked with a number of EDC systems and providers and must be able to demonstrate your experience gained within EDC Data Management.  You will have a broad knowledge of the Pharmaceutical Industry, associated regulations and a full understanding of the role of the Contract Research Organisation (CRO) in Clinical Research.

 Experience of leading complex Oncology studies is highly desirable and you must have managed the EDC Data Management aspects of a number of large and complex studies simultaneously, using your excellent management and communication skills across all disciplines and at all levels to ensure success.

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.

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.

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

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.

Job Description

Project Leader - Data Management

Your responsibility will be:

•           Serve as primary contact for DM with Clinical Operations or Sponsor

•           Create study specific Data Management documents such as Data Management Plan, User Acceptance Test Plan, Edit Check Specifications

•           Plan and review of trial related data management activities

•           Design of Case Report Forms

•           Design and set-up of clinical databases

•           Perform data validation and data clarification

•           Assist in medical coding

•           Ensure the quality of deliverables

•           Work concurrently on multiple projects

•           Escalate and follow-up on project issues as appropriate

•           Supervise supporting colleagues

•           Inform management if there is a requirement to deviate from agreed budget, timelines or resources or of potential Out Of Scope activities

•           Assemble files and ensure documents for the trial master file accurately reflect the progress of the study

•           Liaise with all other appropriate departments within the company to ensure smooth running of the study

•           Provide inputs into SOP review and ability to write effective SOPs in DM

•           Work in a timely manner in accordance with all the activities specified in the agreed study budget

•           Attend and present at Investigator meetings as required

•           Attend and present at bid defences

Experience/Qualifications required

•           Good knowledge of the English and German languages (spoken and written)

•           Ability to organise multiple ongoing tasks, and understand the differing priorities

•           Proven experience in clinical research with a strong knowledge of SOPs and accepted practices

•           Confident dealing with external and internal clients and providers

•           Ability to be proactive and take initiative

•           Proven ability for working independently with minimal supervision

•           Good team player with excellent interpersonal and communication skills

•           Experience in using EDC systems (e.g. InForm, DataLabs, Rave)

•           Willingness to travel

Job Description

We are currently seeking to recruit for this critical position.  The successful applicant will be joining one of the largest niche data management CROs in Europe.

  As part of our management team the successful candidate will:

• contribute to the ongoing strategic development and growth in the company
• have day-to-day responsibility for ensuring that the Data Management Department supports these objectives
• provide the vision and goals for the department aligned with the strategic objectives of the company
• manage the department via an open approach with a strong team based approach 
• have overall responsibility for the recruitment, retention, training and development of your data management colleagues 
• demonstrate expertise in the compilation of departmental and project based budgets and be able to contribute positively to the ongoing profitability of the company
• drive standardization and implement new technologies

 We offer a competitive package which includes health care cover, pension, death in service cover, relocation in addition to Child Care Vouchers and membership of our Sports and Social Club.

Experience/Qualifications required

Applicants must:

• have extensive Management and leadership experience gained within a pharmaceutical or CRO environment
• have a sound understanding of the clinical development process
• have experience of EDC systems
• have been involved in managing change
• be able to demonstrate excellent interpersonal skills
• naturally motivate and coach teams
• be enthusiastic and encourage your teams
• be proactive
• be a self-starter as well as a team player

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.

Job Description

Our client offers a competitive employment package which includes health care cover, pension, death in service cover and relocation and additionally Child Care Vouchers and membership of its Sports and Social Club.                  

 Background:

 Our client is one of the largest specialist biometrics CROs in Europe. It is widely recognised as providing a service of the highest quality to the global pharmaceutical and biotechnology industries.

  Summary:

 Our client requires a highly experienced Head of IT to take responsibility for its in-house IT team, IT infrastructure development and the development of relationships with third-party suppliers.

 The Role:

 The successful candidate will be responsible for managing a team of developers (internal and external) as well as overseeing the IT infrastructure team – this will require hands-on knowledge of development projects, DBMS, web hosting platforms, web database servers, desktop PCs, networks and telephone systems.

 This is a senior management position, and in addition to heading the IT team you will be responsible for assessing and researching future technologies, compliance, licensing, system and IT strategies, and reporting to the Management Board.

Experience/Qualifications required

Skills:

 You will be a confident ideas person who enjoys working in a challenging but positively rewarding environment. You need to be structured and well organised and able to clearly communicate at all levels within the organisation.

 Candidates will need to be able to demonstrate their man management skills - driving a small but diverse team with a dynamism which is infectious.

  Experience:

 The successful candidate will have come from a web/software development/database background and have experience of the full development life cycle within a quality system.  You will also have had previous experience of overseeing an advanced network/server environment.

 Experience of SQL, JAVA, XML and Adobe LiveCycle is desirable and if you have industry specific experience of CDISC standards then that will be an added bonus.

Job Description

This is a key role within the organisation to develop and implement an ongoing EDC / CTMS system within a CRO environment for the collection and management of clinical trial data. The role of the IT Project Manager is to create and execute project work plans in order to finalise the project according to strict deadlines, regulatory requirements and within budget. This includes acquiring resources and coordinating the efforts of team members and third-party contractors or consultants in order to deliver the project according to plan. The IT Project Manager will also define the project’s objectives and oversee quality control throughout its life cycle.

 Responsibilities

 Strategy & Planning

·         Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.

·         Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.

·         Liaise with project stakeholders on an ongoing basis.

·         Set and continually manage project expectations with team members and other stakeholders.

·         Plan and schedule project timelines and milestones using appropriate tools.

·         Track project milestones and deliverables.

·         Determine the frequency and content of status reports from the project team, analyse results, and troubleshoot problem areas.

·         Define project success criteria and disseminate them to involved parties throughout project life cycle.

·         Conduct project post mortems and create a recommendations report in order to identify successful and unsuccessful project elements.

·         Develop best practices and tools for project execution and management.

·         Minimize risk on entire project

 Acquisition & Deployment

·         Estimate the resources and participants needed to achieve project goals.

·         Draft and submit budget proposals, and recommend subsequent budget changes where necessary.

·         Where required, negotiate with other department managers for the acquisition of required personnel from within the company.

·         Determine and assess need for additional staff and/or consultants and make the appropriate recruitments if necessary during project cycle.

 Operational Management

·         Manage day to day operational aspects of the project and scope

·         Direct and manage project development from beginning to end by applying agreed project methodology and enforcing project standards.

·         Develop full-scale project plans and associated communications documents.

·         Delegates tasks and responsibilities to appropriate personnel.

·         Identify and resolve issues and conflicts within the project team.

·         Identify and manage project dependencies and critical path.

·         Develop and deliver progress complete and accurate reports, proposals, requirements documentation, and presentations and ensure they are stored appropriately.

·         Proactively manage changes in project scope, identify potential crises, and devise contingency plans.

·         Manage the budget via tracking and report hours and expenses on a weekly basis.

·         Coach, mentor, motivate and supervise project team members and contractors, and influence them to take positive action and accountability for their assigned work.

·         Review deliverables prepared by team.

·         Ensures compliance with standard procedures, regulations and guidelines.

·         Build, develop, and grow any business relationships vital to the success of the project.

·         Liaise and manage sub-project managers

Experience/Qualifications required

Knowledge & Experience

·         Extensive experience working for a clinical CRO with specific focus on developing and implementing EDC and web reporting tools

• Experience of current and awareness of emerging EDC systems.
• 5+ years direct work experience in a project management capacity, including all aspects of process development and execution.
• Proven track record at delivering projects on time and within budget
• Knowledge of software validation within a clinical research environment
• Experience of data management principles as applied in an EDC environment
• Experience of project management methodologies such as waterfall, agile etc.

·         Ability to develop the best project management tools and use of software appropriate to delivery of such a project

·         Experience of CDISC / CDASH standards

·         Demonstrated experience in personnel management.

·         Experience of Adobe products an advantage

Personal Attributes

·         Experience at working both independently and in a team-oriented, collaborative environment is essential.

·         Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.

·         Reacts to project adjustments and alterations promptly and efficiently.

·         Flexible during times of change.

·         Ability to read communication styles of team members and contractors who come from a broad spectrum of disciplines.

·         Persuasive, encouraging, and motivating - strong, inspiring, motivational  leader

·         Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments.

·         Ability to defuse tension among project team, should it arise.

·         Ability to bring project to successful completion through political sensitivity.

·         Strong written and oral communication skills.

·         Strong interpersonal skills.

·         Effective communicator

·         Manages change effectively

·         Adept at conducting research into project-related issues and products.

·         Must be able to learn, understand, and apply new technologies.

·         Customer service skills an asset.

·         Ability to effectively prioritize and execute tasks in a high-pressure environment is crucial.

·         Tenacious.

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

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).

Job Description

·        Managing fully independently the overall coordination of all types of studies (Phase I to Phase III, standard or non-standard project, collaborative, multi country) according to ICH/GCP and CLIENT SOPs for a large, complex project (complex environment - large number of countries and regions where supra-study coordination is key, multi-subproduct, big efficacy studies with > 10.000 subjects) or a series of smaller projects regrouped for a common characteristic (e.g. early product).

 ·        Ensurance of operational assessment and making final and complex operational decisions regarding project/studies. Being the reference for study management and coordination.  Interact with senior management (ex. lead CDM) or project team to advise and ensure the best operational approach and ensure liaison with other departments (Vaccines Supplies for Clinical Studies - CTSU, Laboratory and Serology Analysis -CIPLA, ..).

 ·        Responsibility for operational risk evaluation at project level (prioritisation) and proposal of strategies to meet overall timeline goals. If applicable define, develop and follow-up KPIs.

 ·        Definition and driving of business cases for process improvements/adaptations and think mid/long term, value added/cost effectiveness, ensure all key partners are involved and committed.

 ·        Development and provision of status reports for different types of management meetings and senior management, analyse situation at the central and local level, establish appropriate action plan and follow its implementation. Involve Regional Clin Ops Heads and other key partners as appropriate.

 ·        Budget : review, negotiate and approve SBB for study management, monitoring and logistics costs

 Review and select external vendors in collaboration with the Outsourcing Manager, Procurement and Legal. Facilitate the development of contracts (advise on requirements for getting realistic bids, contract, and price).

Experience/Qualifications required

Knowledge:

 -       Excellent knowledge and understanding of Global Study Management roles and activities

-       Advanced knowledge ICH-GCP

-       Excellent knowledge of written and spoken English; knowledge of French is an asset.

-       Knowledge of Regional organisation and understanding of Local Operating Countries structure

-       Intensive knowledge of project vaccine, CDP, Target Product Profile for her/his project and knowledge of competitor vaccines.

 Experience:

 -       At least 8 years experience in clinical trials environment and ideally minimum 3-4 years in a GSM role or similar (preferably within CLIENT Bio )

-       Proven experience in clinical project planning, implementation and issues resolution.

-       Experience with supported studies and/or investigator driven studies

 Qualifications:

 University degree in sciences or equivalent background

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.

Job Description

Our client is a global telecoms solutions provider with approximately 5,000 employees in more than 30 countries worldwide, They are a leader in connecting the world's enterprises, governments and employees worldwide, all while providing a customer experience that's hard to match. They provide a fast-paced, challenging and supportive environment in which to grow.

 This senior manager role will manage the design and coordinate preparation of highly complex sales proposals. Review, interpret and author basic RFP response to customers. Coordinate with Account Executives, Project Managers, Technical Engineers and Analysts to develop technical specifications for highly complex proposals.

 Create final documented response/solution based on input from peer group. May mentor lower level employees or act as a team leader. May sometimes assist in project management of the RFP response in coordinating and qualifying responses and representing the Complex Bid Team at internal or external customer bidder conferences.

 Periodically review training requirements and co-ordinate as required. Act as quality analyst in identifying limitations associated with current product offerings, operations, customer service and billing systems/processes.

Experience/Qualifications required

Requires extensive directly applicable experience, which may include technical writing or general business.

 Must have excellent communication skills 

Ability to establish effective mutual understanding and dialogue with colleagues, clients and suppliers

Teamwork and Interpersonal Skills

 Ability to build internal/external customer relationships through fast response, global awareness, high performance, and dedicated teamwork

Quality of Work

 Displays and/or drives top quality deliverables

Min. education requirements: typically requires a degree in a related field but we will consider applicants with a proven successful track record in bids and tenders management with potential to fill this position.

Job Description

Summary:

 To provide regulatory consultancy services to internal and external clients, including preparation, review, submission and project management of regulatory applications.

This is a hands-on role, interacting with companies, regulatory agencies and internally, providing high quality regulatory documentation to support CTA/IND, MAA/BLA, scientific advice meetings and orphan drug applications.

 The Role:

Main accountabilities:

 Strategic

 Maintain an awareness of, and provide feedback on, client, industry and regulatory developments to input into the strategic development of the department.

Operational

 Provide up-to-date regulatory advice to internal and external clients as required.

Prepare, review, submit and project manage regulatory submissions in compliance with the applicable company SOPs, regulatory guidelines and legislation.

Attend client project meetings (face to face and via teleconference) as required.

Maintain electronic and hard copy project and regulatory files.

Participate in business development activities as required.

Provide input into monthly invoicing.

 Management

N/A

 Customer facing

 Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers.

Maintain high levels of customer service to meet client expectations at all times.

Experience/Qualifications required

Experience:

 Candidates should preferably have broad experience of the regulation of medicinal products. 

 Ideally the candidate is already working in regulatory affairs but consideration will be given to candidates with the correct background who wish to move into regulatory affairs.

 Skills:

 Candidates need to have competent IT skills including the use of MS Office Applications, Word, Excel, Powerpoint and Outlook.

 Qualifications:

 Desirable qualifications are BSc / PhD (or equivalent).

Job Description

Summary:

 To provide regulatory consultancy services to internal and external clients, including preparation, review, submission and project management of regulatory applications. This is a hands-on role, interacting with companies, regulatory agencies and internally, providing high quality regulatory documentation to support CTA/IND, MAA/BLA, scientific advice meetings and orphan drug applications.

Strategic

Maintain an awareness of, and provide feedback on, client, industry and regulatory developments to input into the strategic development of the department.

 Operational

 Provide up-to-date regulatory advice to internal and external clients as required.

Prepare, review, submit and project manage regulatory submissions in compliance with the applicable company SOPs, regulatory guidelines and legislation.

Attend client project meetings (face to face and via teleconference) as required.

Maintain electronic and hard copy project and regulatory files.

Participate in business development activities as required.

Provide input into monthly invoicing.

 Management

N/A

 Customer facing

.Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers.

Maintain high levels of customer service to meet client expectations at all times.

Experience/Qualifications required

Experience:

 Candidates should preferably have broad experience of the regulation of medicinal products. 

 Ideally the candidate is already working in regulatory affairs but consideration will be given to candidates with the correct background who wish to move into regulatory affairs.

 Skills:

 Candidates need to have competent IT skills including the use of MS Office Applications, Word, Excel, Powerpoint and Outlook.

 Qualifications:

 Desirable qualifications are BSc / PhD (or equivalent).

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

Job Description

Our client is a well known and fast growing large Pharma company who are seeking an Associate Director of Regulatory Affairs – EU CMC.

 The Associate Director of Regulatory Affairs – EU CMC will formulate and implement CMC regulatory strategy from an EU perspective, provide guidance to program teams and sub-teams, and resolve complex issues related to the projects. The Associate Director of Regulatory Affairs will assure compliance with program team timelines and milestones.

 Primary roles include:

 • Utilizing regulatory expertise and knowledge of EU region regulatory requirements and regulations to strategically interpret, plan, and communicate CMC requirements to franchise teams, program teams and CMC sub-teams.

• Acting as a point of contact for the assigned products and projects and interfacing with key corporate functional areas, particularly with Research, Development and Clinical on early and late stage product development.

• Leading activities associated with market applications and ensuring governmental approvals.

• Maintaining professional relationships with health authorities and other outside contacts.

 Key Responsibilities

 The Associate Director of Regulatory Affairs is responsible for:

 • Providing guidance and regulatory support for the design and execution of CMC activities in support of the development and commercialization of products

• Interacting with other line functions in the preparation, review, and completion of documents for EU regulatory submissions, and setting strategy for submissions of product registration documents to EU health authorities

• Preparing CMC aspects of regulatory submissions including investigational new drug applications (INDs), clinical trial applications (CTAs) in the EU, and marketing applications and supporting changes to INDs, MAAs, and/or pending applications

• Coordinating meetings with regulatory agencies including rehearsals, moderating agency meetings, and preparing briefing document and meeting minutes of these meetings .

• Supporting Regulatory Department activities as appropriate.

Benefits package includes competitive base salary commensurate with experience, company car, annual bonus, stock options, 25 days holiday, medical monthly allowance for medical, dental and vision, retirement plan, and other benefit programmes.

 Minimal travel (10%) anticipated

Experience/Qualifications required

Education and Experience Requirements

 • R.N. / B.S / M.S / Pharm. D. or Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field, advanced degree preferred.

• Extensive drug development and regulatory strategy experience

• Demonstrated regulatory experience supporting investigational or marketed products

• Regulatory knowledge in the EU required.

• Effective communication skills both verbal and written, and strong ability to interact with other departments and external organizations

• Ability to manage multiple projects and complex timelines in a team environment

• Well organized and detailed-oriented

• Excellent analytical skills

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

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

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.

Job Description

 Summary:

Our client is a leading, therapeutically focused CRO that applies comprehensive therapeutic expertise to partner sponsors in achieving its drug development goals.

 Our client now requires a self-motivated Regulatory Affairs Manager with strong interpersonal skills in a fast-paced, deadline orientated environment that will offer an experienced and confident candidate great autonomy and future advancement opportunities combined with an excellent remuneration and benefits package.

 The Role:

 The Regulatory Affairs Manager provides project representation and input to projects awarded for all stages of the drug development cycle. You will provide expert regulatory advice and contribute to regulatory project work as well as manage and co-ordinate regulatory and ethics submissions.

 You will be involved across all levels as you may also be required to line manage/ train/ coach/ mentor other junior staff, as well as deputise for the Regulatory Affairs Director, as required.

Experience/Qualifications required

Experience:

 The main criterion for this role is international expertise in Regulatory Affairs, specifically throughout the EMEA, Asia Pacific and Latin-American regions.

 An expert knowledge of drug development, ICH GCP and the EU Clinical Trials Directive/National Regulations is required as is experience in Clinical Trial Applications, Marketing Application Authorisations, Amendments, Urgent Safety Measures and End of Trial Notifications.

 You will have proven leadership and organisational skills with excellent verbal and written communication ability.  You will be able to exercise sound judgment and make decisions independently and be proficient in all MS Office applications.

 Qualifications:

 Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent, as well as previous experience of clinical trials within a pharmaceutical company or CRO setting.

Job Description

Job Purpose:

 To provide regulatory consultancy services to internal and external

clients, including preparation, review, submission and project

management of regulatory applications. To act as the central point

of contact for assigned key clients. To work with other  staff to

promote and develop the business.

 Main accountabilities:

 Strategic

 • Maintain an awareness of, and provide feedback on, client,

industry and regulatory developments to input into the strategic

development of the department.

Operational

 • Provide up to date regulatory advice to internal and external

clients as required.

• Prepare, review, submit and project manage regulatory

submissions in compliance with the applicable  SOPs,

regulatory guidelines and legislation.

• Attend client project meetings (face to face and via

teleconference) as required.

• Maintain electronic and hard copy project and regulatory files.

• Participate in business development activities as required.

• Participate in/present at internal and external training courses

and conferences as required.

• Provide input into monthly invoicing, and maintain financial

control of assigned projects.

• Mentor other members of the organisation as required.

 Management

  N/A

Main accountabilities:

 Customer facing

.• Develop and maintain effective working relationships with internal

and external clients, regulatory authorities and suppliers.

• Maintain high levels of customer service to meet client

expectations at all times.

Estimated time allocation

 Strategic: 10%

Operational: 70%

Management: 0

Customer facing: 20%

KPI’s:

 • Values behaviours

• Approved regulatory submissions

• Client feedback

• Amount of time spent on billable work

Experience/Qualifications required

PERSON SPECIFICATION

Essential Skills:

 VALUES Behaviours

• Excellence

• Drive

• Ownership

• Challenge

• Teamwork

• Respect

 Business Skills

• Organisation and Planning - Level 2

• Analytical Skills – Level 2

• Problem Solving and Decision Making – Level 2

• Communication – Level 1

• Networking and Relationship Building – Level 1

 Technical/Specialist

• A sound technical and scientific understanding of one or more of

manufacturing, non-clinical or clinical development of

pharmaceutical/healthcare products

Desirable Skills:

• Competent IT skills including the use of MS Office applications

Word, Excel, Powerpoint and Outlook

Work Experience & knowledge:

• Experience from working in a pharmaceutical/healthcare product

development environment.

• An overall understanding of the drug development process and the

role of regulatory affairs within that process

Education level:

BSc

Degree required:

Science

Prof. qualifications:

N/A

Other (please specify)

N/A

Part of what makes this client successful is the highly motivated people who work here and their enthusiasm for what

we do and stand for! We recruit individuals whose passion, drive, integrity, initiative and customer orientation

shines through. An inspiration to your colleagues and your team, you are a motivated individual who can instil

trust and confidence in customer relationships whilst having a natural aptitude for getting the best out of people.

You will inspire others through your commitment, motivation, expertise, professional manner and always placing

the customer at the centre of everything you do. All employees at this client have certain shared responsibilities and

these include:

- to maintain and promote the reputation of this client as an ethical and expert consultancy company

- to maintain the confidentiality of patient, client and company information

- to maintain good professional relationships with all external parties in contact with this client, including

clients, suppliers, consultants and clinical trial investigators

- to maintain good working relationships with colleagues and to enable a team spirit within the company

- to contribute ideas on matters affecting the running of the company

- to maintain an awareness of the business of the company and of all ongoing projects

- to be organised in the planning of personal workload

- to ensure that person development is maintained through continuous training assessment

- to maintain technical expertise as appropriate

- to be conversant with client Standard Operating Procedures

Job Description

To provide regulatory consultancy services to internal and external

clients, including preparation, review, submission and project

management of regulatory applications.

Main accountabilities:

 Strategic

 • Maintain an awareness of, and provide feedback on, client,

industry and regulatory developments to input into the strategic

development of the department.

Operational

• Provide up to date regulatory advice to internal and external

clients as required.

• Prepare, review, submit and project manage regulatory

submissions in compliance with the applicable client SOPs,

regulatory guidelines and legislation.

• Attend client project meetings (face to face and via

teleconference) as required.

• Maintain electronic and hard copy project and regulatory files.

• Participate in business development activities as required.

• Provide input into monthly invoicing.

 Management

  N/A

Main accountabilities:

Customer facing

.

• Develop and maintain effective working relationships with internal

and external clients, regulatory authorities and suppliers.

• Maintain high levels of customer service to meet client

expectations at all times.

Estimated time allocation

 Strategic: 5%

Operational: 80%

Management: 0

Customer facing: 15%

KPI’s:

 • Values behaviours

• Approved regulatory submissions

• Client feedback

• Amount of time spent on billable work

Experience/Qualifications required

PERSON SPECIFICATION

Essential Skills:

 VALUES Behaviours

(See attachments)

 • Excellence

• Drive

• Ownership

• Challenge

• Teamwork

• Respect

 Business Skills

• Organisation and Planning - Level 1

• Analytical Skills – Level 1

• Problem Solving and Decision Making – Level 1

• Communication – Level 1

• Networking and Relationship Building – Level 1

 Technical/Specialist

• A sound technical and scientific understanding of one or more of

manufacturing, non-clinical or clinical development of

pharmaceutical/healthcare products

Desirable Skills:

• Competent IT skills including the use of MS Office applications

Word, Excel, Powerpoint and Outlook

Work Experience & knowledge:

• Experience from working in a pharmaceutical/healthcare product

development environment.

• An overall understanding of the drug development process and the

role of regulatory affairs within that process

Education level:

BSc

Degree required:

Science

Prof. qualifications:

N/A

Other (please specify)

N/A

Part of what makes this company successful is the highly motivated people who work here and their enthusiasm for what

we do and stand for! We recruit individuals whose passion, drive, integrity, initiative and customer orientation

shines through. An inspiration to your colleagues and your team, you are a motivated individual who can instil

trust and confidence in customer relationships whilst having a natural aptitude for getting the best out of people.

You will inspire others through your commitment, motivation, expertise, professional manner and always placing

the customer at the centre of everything you do. All employees at the client have certain shared responsibilities and

these include:

- to maintain and promote the reputation of the client as an ethical and expert consultancy company

- to maintain the confidentiality of patient, client and company information

- to maintain good professional relationships with all external parties in contact with client, including

clients, suppliers, consultants and clinical trial investigators

- to maintain good working relationships with colleagues and to enable a team spirit within the company

- to contribute ideas on matters affecting the running of the company

- to maintain an awareness of the business of the company and of all ongoing projects

- to be organised in the planning of personal workload

- to ensure that person development is maintained through continuous training assessment

- to maintain technical expertise as appropriate

- to be conversant with  client Standard Operating Procedures

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

Job Description

The Online Marketing Specialist creates, measures, analyses and optimises online marketing programs, and manages internal partners and external agencies to achieve marketing goals. The Online Marketing Specialist will collaborate with Project Managers, Customer Services, Sales and other functions to create and deploy highly effective online marketing programs, including email campaigns, blogs, co-marketing opportunities, online advertising, SEM and more. This position is both creative, hands on and analytical in nature.

 *Major Responsibilities:

 §  Specify content modifications and design changes to the company website

§  Project Manage the development of a new website while maintaining the existing one

§  Design, implement and manage online marketing programs focusing on building awareness and customer acquisition

§  Understand, optimise and expand our website’s ranking in organic search results (SEO)

§  Write blogs and ensure that key personnel’s profiles are maintained and widely placed

§  Manage online content by means of a Content Management system

§  Manage weekly and monthly reporting and tracking, flagging issues for internal stakeholders and report metrics appropriately

 §  Develop and manage metrics and budgets

§  Analyse and report marketing performance; provide results and recommendations for improvement and new programs

§  Work with Project Managers, Customer Service and Sales to develop and execute highly effective direct response programs to significantly increase inbound lead flow and pipeline generation

§  Effectively manage outside partnerships to maximize ROI on programs

§  Propose new marketing program ideas and then secure support from internal and external stakeholders to fund and execute these programs

§  Develop ad copy, landing pages, banner creatives and other marketing collateral

Provide support for other areas of marketing as needed.

Experience/Qualifications required

§  BA/BSc Degree required

§  Strong written and verbal communication skills

§  Understanding of online marketing a must

§  Passion for Search Engine Marketing

§  Familiarity with CMS (Content Management) systems

§  Familiarity with analysis tools such as Google Analytics

§  Familiarity with search engine ranking tools such as Google AdWords

§  Strong PowerPoint user

§  Must be able to work in an organization where resources necessary for execution do not report directly to this position

§  Search Engine Optimisation skills

§  Ability to identify tactics for constant improvement

§  Self-motivated with a high level of initiative and a sense of urgency

§  Familiarity with web services

§  Strong attention to detail and ability to manage multiple tasks simultaneously

§  Driven to deliver results

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

Job Description

§  Direct and manage project development from beginning to end

§  Define project scope, goals and deliverables that support business goals in

collaboration with senior management and stakeholders

§  Develop full-scale project plans and associated communications documents

§  Effectively communicate project expectations to team members, clients and stakeholders

      in a timely and clear fashion.

§  Liaise with clients and project stakeholders on an ongoing basis

§  Estimate the resources and participants needed to achieve project goals

§  Draft and submit budget proposals, and recommend subsequent budget changes

      where necessary

§  Where required, negotiate with other department managers for the acquisition of required personnel from within the company

§  Set and continually manage project expectations with team members, clients and other stakeholders

§  Delegate tasks and responsibilities to appropriate personnel

§  Identify and manage project dependencies and critical path

§  Plan and schedule project timelines and milestones using appropriate tools as necessary.

§  Track project milestones and deliverables

§  Develop and deliver progress reports, proposals, requirements documentation,

      and presentations

§  Provide project reports as specified, analyze results, and troubleshoot problem areas.

§  Proactively manage changes in project scope, identify potential crises, and

      devise contingency plans

§  Build, develop, and grow any business relationships vital to the success of the

      project

§  Conduct project post mortems and create a recommendations report in order to

      identify successful and unsuccessful project elements

§  Develop best practices and tools for project execution and management.

Experience/Qualifications required

*Requirements: Education, Background and Experience:

§  Relevant university degree or professional qualification

§  Min 3  years direct work experience in a project management capacity preferably in a health related environment

§  Technically competent with various software programs, such as excel and databases

§  Confident to work both independently and in a team-oriented, collaborative

      environment is essential

§  Good communication (verbal and written) and interpersonal skills

§  Conducting research into project-related issues and products

§  Customer service skills essential

§  Must be able to learn, understand, and apply new technologies

§  Interest in health and the management of long term conditions such as Diabetes

§  A willingness to travel to customer and non-customer sites predominantly in the UK, but also worldwide as required is essential

§  Own car and clean driving license

 *Personal Qualities

§  Able to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities

§  Reactive to project adjustments and alterations promptly and efficiently.

§  Flexible during times of change

§  Persuasive, encouraging, and motivating

§  Ability to elicit cooperation from a wide variety of sources, including upper

      management, clients, and other departments

§  Ability to resolve conflicting situations

§  Strong interpersonal skills

§  Ability to effectively prioritize and execute tasks in a high-pressure environment

§  Leadership qualities

Job Description

Our client is one of the largest specialist biometrics CROs in Europe. It is widely recognised as providing a service of the highest quality to the global pharmaceutical and biotechnology industries.                      

 Summary:     The purpose of the role is to provide overall leadership on assigned projects. The Project Manager will be responsible for the overall conduct of the project and accountable for the delivery of the project to quality and scientific expectations, by the timelines set and within budget. The Project Manager is also expected to carry out other duties which might reasonably be requested.

 The Role:

 Project Leadership :           Provide leadership and guidance, trouble-shoot as necessary and provide problem-solving for all team members within each function on assigned projects.

 Business Development :    Assist with the preparation of cost estimates and proposals for clients. Attend client meetings, including bid defence meetings.

Client Management :           Act as primary contact for clients in relation to all assigned project aspects. Ensure client satisfaction and address any client concerns, following up until appropriate resolution. Lead client project meetings and attend (and present at, if applicable) investigator meetings.

 Contracts, Project Finance and Scope Management : Oversee the preparation and tracking of status of Letters of Intent and Project Specific Task Orders, ensure that contracts are in place prior to the initiation of any project-related activities on assigned projects. Ensure that budgets are tracked and kept up-to-date. Prepare financial and project team activity forecasts. Oversee and authorise invoices to clients and payments to subcontractors. Ensure that deviations in scope or time with regard to contracted deliverables and milestones are raised proactively with clients.

 Quality :                                 Responsible for the compliance of studies within assigned projects to statutory requirements. Responsible for compliance with SOPs.

 Project Team Management :        Accountable, on assigned projects, for the overall management of the project team by ensuring that the Project Leads within each service function are appropriately co-ordinating, resourcing, planning and managing the tasks and actions associated with their deliverables. Guide Project Leads on constructing robust function plans and setting internal milestones and project objectives and develop overall project plan(or programme plan, as appropriate), including the function project plans across departments. Devise the staffing structure for each project, perform regular reviews of project status and ensure that project post-mortems are conducted with learning points shared across teams as appropriate and addressed in future project proposals.

 Trial Management :             Oversee timely archiving of project-related documents. Ensure that the required (by SOPs) quality control steps and procedures are followed. Oversee preparation for client and in-house audits and regulatory inspections.

 Risk Management :             Manage the overall project plan and and identify proactively where timelines and deliverables might be at risk of slippage, ensuring that the client is sufficiently and proactively informed of any changes in timelines. Flag cross-project issues concerning resource management, performance management, quality assurance and client satisfaction. Provide programme management across multiple projects. Ensure that each Project Lead has a plan in plkce to address internal and/or external quality issues.

 General :                               Actively contribute to the ongoing development and process improvement of the department and across the company. Keep abreast of regulatory developments and legislation by reading relevant publications, attending courses and through membership of relevant professional associations. Participate in the training and orientation of new staff in the company, as required.

 Experience :                         There is more than one post available so candidates with different levels of experience will be considered.

Experience/Qualifications required

Currently being updated

Job Description

Main function of job (Note: in addition to these functions employees are required to carry out such other duties as may reasonably be required.)

Manage all aspects of the Quality Assurance Function in relation to products, processes and customer satisfaction.  Responsibility and authority to intervene and escalate any non-conformance to regulatory and quality related requirements.

Main duties - brief descriptions

1.

Maintain up-to-date knowledge of medical device regulatory requirements in World markets, in particular Europe, US and Japan, and manage effective quality management systems, conforming to relevant international standards.  Ensure that quality is embedded into business processes and projects and is in line with Company business objectives.

2.

Ensure continued conformance and approval/certification of products and processes to existing and forthcoming regulatory and statutory requirements.

3.

Carry out internal assessments based on mandatory elements of Company Quality procedures.  Report on level of performance and recommend enhancements to internal procedures and working practices where necessary.

4.

Develop Quality input to product design and assist in obtaining relevant product approvals.

5.

Manage internal and external audits and report at regular Quality Assurance Management Review meetings regarding results of design reviews, audits, subcontractor and customer issues and non-conformancies.

6.

Manage customer complaints in terms of the close-out of Quality/Regulatory issues, liaising with Sales/Customer Services to ensure they are in the loop re. final outcome.

Experience/Qualifications required

Engineering background preferred.

Job Description

Summary:

Our client is looking for quick-witted graduates in Computer Science or related subjects, with an interest in medical informatics.

Our client provides an integrated portfolio of advanced software products in clinical trials and decision support.

 Attributes:

Perhaps looking for a first job or a change from a current job, the ideal candidate will be:

- interested in how our client’s solutions help its clients to do their job

- a team player ready to join our client’s agile programming groups

- eager to take responsibility for the quality of his or her work and for supporting end users

- fluent in, or eager to learn, C#, .NET4, ASP.Net, web application, SQL Server/Oracle, Silverlight

- ready to learn about quality management, clinical regulation, and clinical ethics

If not all of the above criteria are met, our client might be prepared to train candidates who demonstrate the right attitude and personality

Experience/Qualifications required

Experience:

 If the candidate has experience in, or an understanding of, logic programming / declarative programming styles, then this would be a bonus.

 Qualifications:

 Educated to degree level

Contact:

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

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

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

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.

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

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

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.

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.

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.

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

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

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

Job Description

Biostatistician in charge of internal statistical consulting to solve practical problems in diversified R&D fields (pre-clinical, clinical labs validation, formulation, fermentation, purification, cell culture, molecular biology).

• Providing internal statistical consultancy support, which entails a.o. a close interaction with other CLIENT Bio teams such as biologists, engineers and technicians. This support consists of the definition of the questions, statistical support, explanation of the used method and achievements, common interpretation, writing a synthetic report, participation to meetings

• Identifying opportunities of using statistics within the field of the R&D of new vaccines

• Guaranteeing the quality of identified solutions, their implementation & execution, their results and the respect for the defined timelines

• Active contribution to keep the team up-to-date regarding methodologies and their practical translation (algorithms, tools, macros, codes, …).

Experience/Qualifications required

Skills and Knowledge:

• Very good practice of multi-way ANOVA models (nested, mixed, random, repeated) and non-linear modelisation/optimisation.
• Mastering of SAS/BASE, SAS/STAT, SAS/GRAPH, macro-language SAS, Visual Basic Application for Excel and Word.
• Fluency in French and English (oral and written).
• Reactive and highly motivated referring frequent change in type of job
• Willingness to well understand biological problems and constraints of researchers before proposing adequate solutions applicable in a multi-disciplinary project context.
• Creative and innovative with respect to statistical methodologies
• Responsible
• Team player, ability to share knowledge with the team
• Good practitioner: being able to liaise theory with the practical translations and share experience

Experience:

Ideally minimum 10 years of statistical experience in a research environment (by preference in the private, pharmaceutical or biotechnology sector).

 Qualifications:

• University level in Sciences (Bio-engineering, agronomy, science or maths) with a post-graduate in Biostatistics (or DEA, DES, DESS ) or equivalent experience
• PhD would be a plus
• Effective communication and presentation skills to non-statisticians

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.

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.

Job Description

We are looking for junior statistical programmers willing to work in Belgium (Turnhout) for a year.

Experience/Qualifications required

Candidates should have 2 or 3 years of SAS programming experience and practical knowledge of CDISC. They should be qualified to BSc/MSc level.

Job Description

The candidate will coordinate and perform research within the framework of a project aimed at the discovery and validation of biomarkers for Alzheimer's disease. The project includes both methodological (development of novel approaches to validation of biomarkers by using historical data) and applied (application of the developed methodology to existing experimental and clinical data) aspects. The candidate will closely collaborate with researchers at CenStat.

Experience/Qualifications required

• Master or PhD in biostatistics, statistics or mathematics
• Previous experience in clinical research preferable
• Extensive experience in the use of statistical/mathematical software such as SAS, R, Mathlab is strongly recommended
• Good knowledge of English language, written and spoken
• Problem solving skills, team player, organized and focused
• Thinks analytically and creatively
• Enjoys working in a multidisciplinary environment (statistics, computer sciences, molecular biology, biochemistry).

Job Description

Key Tasks

Project work

Oversee and contribute to statistical programming, as required.

Ensure adequate processes for programming and validation is in

place, meeting regulatory requirements and client expectations.

Take overall responsibility for quality and process adherence.

Oversee and contribute to the development and validation of

statistical analysis plans, as required. Ensure adequate processes

are in place for SAP development and QC, meeting regulatory

requirements and client expectations. Take overall responsibility for

quality and process adherence.

Oversee and contribute to the development and validation of

clinical study protocols, in particular statistical sections, as required.

Ensure adequate processes are in place for protocol development

and QC, meeting regulatory requirements and client expectations.

Take overall responsibility for quality and process adherence.

Assign team members in a timely manner to ensure CRF review

takes place.

Oversee and contribute to the generation of randomisation lists

through consultation with sponsors and project teams, or direct

involvement with the randomisation process as appropriate.

Ensure adequate processes are in place for the generation of

randomisation lists and code break envelopes. Take overall

responsibility for the production of randomisation lists and code

break envelopes.

Take overall responsibility for the completeness and accuracy of

statistical study files; ensure team members are assigned to carry

out archiving activities.

Ensure adequate resources are available to carry out tasks to

support DM requirements for client-specific SAS® extraction tools.

Oversee and contribute to the preparation and QC of biometric

reports, as appropriate. Ensure adequate processes are available

for the preparation and QC of reports.

Ensure processes are in place for handling PK concentrations and

parameters; liaise with pharmacokineticists to resolve issues.

Ensure project statisticians and programmers are assigned to project

teams in a timely manner, in order to deliver all project requirements

in a timely manner, and to client and regulatory standards. Prioritise

and delegate studies and tasks, and provide regular feedback on

progress to the Directors, project managers, statisticians, SAS®

programmers, QC auditors and QA auditors, as appropriate. Ensure

responses to QA audits are provided in a timely manner, and

maintain a CAPA log of findings.

Project management & Client Coordination

Liaise with clients and the Directors of Syne qua non as appropriate,

on the management of projects and tasks within the statistics

department. Attend project/client meetings as required.

Ensure adequate resources and infrastructure are available to

develop and maintain knowledge bases for clients' requirements.

Ensure team members are assigned in a timely manner, and are

available to attend team meetings, as required.

Assess resource needs and any out of scope work required, and

provide feedback to the Directors, project managers, statisticians,

SAS® programmers, QC and QA function as appropriate.

Keep track of project timelines; communicate changes to the

Directors, management, project management, Finance as

appropriate.

Assess resource needs for projects, and assign project statisticians

and other team members in a timely manner. Delegate projects

and tasks to ensure timely delivery in accordance with regulatory

and client requirements. Review assignments regularly to ensure

they meet project requirements.

Ensure adequate representation of the statistics department at client

audits; attend close out meetings as appropriate. Provide responses

to audit findings, and maintain CAPA log to monitor progress on

follow-up.

Provide financial oversight of the statistical aspects of project work

ensuring that SQN financial processes are applied consistently.

Training

Keep training record up to date.

Take overall responsibility of training activities within the statistics

department; identify training needs, and organise training as

required. Prepare training material as appropriate.

Organise internal training as necessary, present training material at

departmental meetings, as required; identify training opportunities

and suitable trainers. Present Statistics induction as part of the

company wide induction program.

Experience/Qualifications required

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

Job Description

• Responsibilities include:

·         as a statistical consultant, work with clients in developing study protocols, provide advice on design options, sample size considerations etc.

·         perform ad-hoc exploratory analyses, for example to support publications

·         represent client in external meetings, e.g. with health authorities, KOLs, steering committees, DSMBs etc.

·         act as lead statistician on assigned projects (more than one project at the time), being accountable for quality, timelines, budget

·         responsibility for SAP authorship, including statistical methods, TFL shells

·         production of TFLs for clinical study reports - work with programmers and support statisticians on correct interpretation of SAP; develop and validate programs, in particular for statistical analyses

·         input into study report or stand-alone biometric report

·         contribute to business development activities (input into quotations and proposals, preparation of and attendance at bid defence meetings, exhibitions).

·         Note a moderate amount of travelling, both domestic and internationally, may be necessary for some of these activities, depending on client and project requirements.

Experience/Qualifications required

·         Requirements:

·         Post-graduate qualification (MSc, PhD) in statistics or a related discipline.

·         At least 5 years clinical trials experience as a biostatistician in the pharmaceutical industry or a CRO

·         Awareness of GCP requirements, should have received GCP training in the last 12-18 months, must have worked to SOPs and maintained trial documentation

·         Has worked on study design / sample size calculations / protocol development, preferably for early phase studies

·         Experienced in translating medical problems into statistics

·         Can independently decide on appropriate statistical methods to be used, and formulate them in a statistical analysis plan

·         Preparation and QC of analysis plans, including the preparation of table and listing shells ("mock tables") is an integral part of this job, and we are looking for someone who has done this for at least 3 years

·         Prior experience of leading study teams in the production of tables, figures and listings for clinical study reports, especially validation and quality control (QC) aspects

·         Experience with several therapeutic areas, with preference for oncology, other areas may be cardio-vascular, CNS, PK

·         Good familiarity with commonly used statistical methods, such as ANOVA/ANCOVA, linear mixed effects models, survival analysis, sample size calculations, multiple comparisons, handling of missing data, dose-proportionality, bio-equivalence, non-parametric methods, etc.

·         Must have good knowledge of SAS; other statistical packages would be an advantage

·         Prior involvement in process development (SOP writing/review) or process improvement initiatives

·         Excellent oral and written communication; has experience giving presentations to statisticians and/or non-statisticians 

·         Team player, good organisational skills, flexibility, ability to work on several projects simultaneously, very good attention to detail required

·         Problem solving - brings solutions not problems

 We offer a competitive package which includes pension and death in service cover, in addition to Child Care Vouchers and membership of our Sports and Social Club.