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Data Management

Last updated: 09:57 05/03/2013

Senior Data Manager

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

Job Description

Salary and Benefits:                       £36k to £38k

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

 A Childcare Voucher scheme is also in operation.

 

Summary:

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

  The Role:

 ·         To process clinical data for allocated projects.

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

·         To code adverse events, medical history and medications.

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

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

·         To report progress against schedules to management as appropriate.

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

·         To carry out systems validation work as requested.

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

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

·         Mentoring and training of DM staff

·         Process review and improvement

·         Department point of contact

·         Assessment of project resource

·         Assist with project budget

·         Business development support including costings and client liaison

·         To perform other reasonable tasks as requested by management.

Experience/Qualifications required

Skills and Attributes:

 ·         Understanding of data management and regulatory requirements.

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

·         Excellent accuracy and attentiveness to detail.

·         Excellent written and oral communication skills.

·         Good organisational skills and interpersonal skills.

·         Ability to work alone or within a team environment.

·         Ability to manage competing priorities in a changeable environment.

·         Ability to handle work to tight deadlines.

 Experience:

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

 Qualifications:

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

 

Senior Clinical Data Manager

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

Job Description

Summary:

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

 The Role:

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

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

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

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

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

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

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

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

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

·       Proactive planning and forecasting of workload requirements 

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

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

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

·       Identify and manage changes in scope.

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

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

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

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

·         Prepare for and participate in internal and external audits.

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

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

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

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

·         Contribute to departmental processes and technical improvement efforts.

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

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

·         Performs other tasks as assigned by line manager.

Experience/Qualifications required

Skills and Attributes:

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

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

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

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

·         Work calmly under pressure and meet deadlines

·         Professional, positive, dynamic and driven

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

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

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

·         Good negotiation and problem solving skills

·         Transparent approach, clear and precise

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

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

·         Eagerness to learn and develop new skills

 Experience:

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

 
 Qualifications:

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

  • Foreign language skills would be advantageous.

Senior Data Manager

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

Job Description

Summary:

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

The Role:

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

Experience/Qualifications required

Skills and Attributes:

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

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

 

Experience:

 

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

 

Qualifications:

 

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

Senior Clinical Database Programmer

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

Job Description

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

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

Clinical Systems and Support Programmer and Database Programmer.

 Relationships

Reports to Manager, or above

Directly Supervises N/A

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

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

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

External Relationships:  Sponsors, Third Party Vendors, Auditors

Experience/Qualifications required

 Database Programmer

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

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

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

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

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

 Skills:

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

• Knowledge of the programming and reporting process within GRO.

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

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

• Strong leadership ability.

• Attention to detail.

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

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

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

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

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

• Work effectively in a quality-focused environment.

• Demonstrate commitment to refine quality processes.

Language skills:

• Excellent English written and oral communication skills.

 Experience:

 • Relevant Clinical Trial industry experience

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

 Qualifications:

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

Clinical Database Programmer II

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

Job Description

Summary:

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

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

Clinical Systems and Support Programmer and Database Programmer.

 

 The Role:

Reports to Manager, or above

Directly Supervises N/A

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

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

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

Clinical Systems and Support Programmer

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

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

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

applications/systems

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

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

• Execute automatic import and export of data.

Database Programmer

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

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

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

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

 

Experience/Qualifications required

Skills:

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

• Knowledge of the programming and reporting process within GRO.

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

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

• Attention to detail.

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

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

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

• Work effectively in a quality-focused environment.

 Language Skills

• Very good English written and oral communication skills.

 Experience:

 • Relevant Clinical Trial industry experience

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

 Qualifications:

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

Senior Data Manager

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

Job Description

Job Description:

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

 Purpose of Job

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

 Major responsibilities

 Managing the Biometrics Team

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

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

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

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

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

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

 Managing Outsourced tasks

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

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

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

 Coordination and Communication

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

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

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

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

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

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

 Implementation/review of Systems and Procedures

•           Overseeing development and maintenance of data management and statistics  SOPs

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

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

 Training and Support

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

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

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

•           Input into training records for Biometric team members.

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

•           Sourcing of essential training material.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 Other responsibilities

•           Taking a lead role in external and internal Biometrics audits

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

•           Budget generation and notification of out of scope activities

Experience/Qualifications required

Candidate Requirements:

Experience

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

•           Relevant Clinical Research experience

•           Project management experience

•           Line management experience (preferable)

•           Technical expertise with clinical trial software and databases

•           Familiarity and a good understanding of statistical analysis and programming

 

Essential knowledge/skills

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

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

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

•           Excellent written and verbal communication skills

•           High level of interpersonal skills, a good team player

•           Proactive

•           Motivated and enthusiastic

Database Programmer II

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

Job Description

Job Description:

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

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

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

Experience/Qualifications required

Candidate Requirements:

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

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

 This is a permanent position.