Clinical Data Reviewer (remote working)
- Experience Level
- Experienced (non-manager)
Clinical Data Reviewer
This role would suit a study Co-ordinator, Research Sister, CRA or a field monitor with relevant data review experience.
- Full-time contract position
- Minimum 6 month contract to start ASAP
- Remote working (based in the UK)
- Global pharma company
- Competitive hourly rate
- The Clinical Data Reviewer (CDR) is a highly specialized role that performs clinical data review, typically ahead of significant project milestones (interim analysis, study closeout, submission etc.).
- The studies supported by the CDR are often, but not exclusively, complex comparative safety and efficacy (phase 3) trials with large, multi-faceted data sets.
- The review tasks performed by this role include both point-to-point clinical data checks and interpretive analysis
- This requires that the CDR be knowledgeable about the therapeutic area under investigation (Oncology) expected effects of the investigational drug and concomitant medications, and possess sufficient clinical knowledge to assess if patient data is scientifically and clinically valid.
Full details available on application
- Candidates should have a life science degree or nursing background;
- At least 7 years of clinical experience in pharmaceutical industry;
- A thorough understanding of the processes associated with reviewing and delivering quality data;
- Deep Clinical Research experience in the phase 3/pivotal space, ideally on the side of the sponsor and with a track record of successful regulatory submissions;
- Strong background in Oncology;
- Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines;
- Familiar with Oracle Clinical Remote Data Capture and/or other database systems; technically competent with Microsoft Excel and ideally, Access;
- Possesses at least basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports
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