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Vacancy details
Vacancy description:
Job Code:
00308
Job Title:
Clinical Data Manager (Contract)
Job Category:
IT & Data Management
Contract:
Locum/Temporary
Discipline:
Data Management, Clinical Data Coordinator
Country:
United States Of America
Location:
Massachusetts
Min experience:
3 years
Annual salary:
Negotiable
Apply by:
05 Jun 2008
Our client, a global Contract Research Organisation, is building a Rapid Response Data Management team and requires experienced Clinical Data Managers for office based, permanent or contract positions, in Quincy, MA (a suburb of Boston). This company provides a full range of services from programme/trial design to medical report writing for the biopharmaceutical industries, covering a wide range of therapeutic areas and including every phase of clinical development.
JOB ROLE: These roles serve as the Project Data Manager/s with primary responsibility for managing data management activities for medium sized studies in accordance with contractual obligations, timelines and budget as well as Company SOPs, WIs and Project Specific Guidelines. He/she may supervise the Data Processors with regard to data processing and deputise for Senior Data Manager.
PRINCIPAL RESPONSIBILITIES include:
•Developing the data management manual, CRFs, eCRFs or annotated CRFs.
•Performing peer review of data management manual, data validation plans etc. prior to delivery to the client.
•Reviewing CRFs, monitoring conventions and protocols where appropriate.
•Creating or supervising the creation of test data for validating data entry screens and data validation programmes.
•Testing or supervising the testing of validation programmes.
•Leading or coordinating database set-up, data imports, exports and lock activities for studies.
•Coding medical terms in accordance with coding conventions.
•Reconciling data between databases.
•Generating and reviewing listings using data review tools.
•Training and providing support to the Data Processors and Data Coordinators.
•Performing database QC if appropriate.
•Participating in client audits and proposal presentation.
•Managing the data management aspects of full service projects and small stand alone projects.
•Identifying and providing estimates for changes of scope.
•Participating in process improvement efforts.
•Participating in the development, training and updating of SOPs, Working Instructions and departmental policies.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
•Education to University degree or significant experience in clinical research, drug development or health care environment will be required.
•Approximately 3-4 years data management experience in a CRO, Pharmaceutical or Biotech Company.
•Skills in discrepancy management tools of Oracle Clinical or ClinTrial are an advantage.
•The ability to programme in SAS is an advantage.
•Working knowledge of ICH/GCP and regulatory obligations is essential.
PERSONAL SKILLS & ATTRIBUTES:
•Attention to detail.
•Good communication, listening and presentation skills.
•Strong planning, organisational and documentation skills.
BENEFITS OF THE ROLE: Are you an innovative thinker aiming high in your career? Our client is known to hire and keep their highly dynamic and talented employees and encourages each individual to develop his or her skills to attain their goals. They are an equal opportunities employer valuing the diversity of their workforce and providing a supportive work environment for everyone. Their remuneration will be competitive based on your experience and skills.
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors.
KEY WORDS: Clinical Data Manager, Clinical Data Management, Data Manager, Data Management, CDM, DM, Project Data Manager, Clinical Projects, Database Set-Up, QC, Quality Control, Clinical Research, Drug Development, Oracle Clinical, ClinTrial, SAS, ICH, GCP, CRO, Pharmaceutical
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