Clinical Data Reviewer
Here is an exciting pharmaceutical job one of the industry's most prestigious organisations. There is a vacancy for a Clinical Data Reviewer to join a global top 10 pharmaceutical company at their offices located in Surrey.
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, expected effects of the investigational drug and concomitant medications, and possess sufficient clinical knowledge to assess if patient data is scientifically and clinically valid.
- The CDR may be responsible for the clinical data review of one or more studies with the ability to move easily from project to project as necessary.
- The CDR has comprehensive knowledge and understanding of the therapeutic area under study and uses that knowledge to ensure that patient data are scientifically and clinically valid. 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 In addition the CDR ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications.
- Review tasks performed by the CDR include both point-to-point data checks (e.g., verifying the presence of a blood pressure value that satisfies study inclusion criteria) and interpretive analysis (e.g., evaluating subject to find inconsistencies the patients data).
- The CDR will create and use data review best practices and associated data review tools to identify trends and any safety signals.
- Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
Skills and Requirements:
- Bachelor's degree in one of the disciplines related to life sciences, drug development or business. Advanced degree is desirable.
- At least 7 years of clinical experience in pharmaceutical industry.
- A thorough understanding of the processes associated with reviewing and delivering quality data.
- Strong field monitoring experience an asset
- 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.
- In addition to the required technical knowledge and experience, a CDR must possess a willingness to perform primarily data review tasks.
- Ability to work proactively and independently, organize tasks, time and priorities of self and others; ability to multi-task
- Collaborative problem solving (handles conflict constructively)
- Able to embody leadership behaviours and competencies
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Magenis on +44 203 854 1050 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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