CK Group are recruiting for a Clinical Data Reviewer to join a company in the Pharmaceutical company industry on a 6 month contract. The role is based in Tadworth in Surrey, however the position gives the Clinical Data Reviewer the chance to be partially remote.
The Clinical Data Reviewer (CDR) performs full-time clinical data review, most often in a submission timeline, and works in conjunction with study teams’ data review. The studies supported by the CDR are often, but not exclusively, comparative safety and efficacy (phase 3) trials that are high-enrolling and require robust data capture.
Review tasks include both point-to-point data checks and interpretive analysis that requires that the CDR be knowledgeable about the therapeutic area under investigation, expected effects of the investigational drug and supportive medications, and possess sufficient clinical knowledge to assess if patient data is logical. They can be flexibly deployed to support multiples assets in different therapeutic areas, as needed.
To be considered for the role you should have the following skills, knowledge and experience:
-Bachelor’s degree or equivalent in life sciences, and significant Clinical Research experience in industry/CRO, in the phase 3/pivotal space. Advanced degree (PhD, PharmD, MD) is an advantage.
-Expertise in conduct of clinical trials, particularly understanding of the processes associated with delivery of quality data, and experience in the review of clinical study data.
-Technical data review skills enabling the review of large sets of clinical data under often challenging timelines, eg. Oracle Clinical Remote Data Capture, Microsoft Excel.
-Understanding of the processes associated with delivery of quality data, including at least basic knowledge of data management (eg. case report forms, electronic edit checks, interpretation of data status reports). Field monitoring experience (CRA role) is an advantage.
-Excellent communication skills (written and spoken) in English.
The CDR would be expected to cooperate closely with the US based group of contract CDRs being managed by the global Data Review Team Lead. Home based work is possible, however, regular presence at the Tadworth offices 1-2 days a week is expected to allow team interaction with clinicians and clinical scientists, and coaching.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA41811 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 13th April 2018
- Expires: 11th May 2018
- Reference: KA41811