Clinical Document Reviewer in Surrey or Home Based
Jenni at CK Group is recruiting for a Clinical Document Reviewer to join a company in the Pharmaceutical industry at their site based in Tadworth, Surrey on an initial 6 month contract basis. This role does come with the option to work fully remote. The Company:
Our client is one of the largest bio-pharmaceutical companies operating in the UK. They are committed to helping the UK develop the talent it needs to achieve the aspiration of being a global leader in life sciences, from the school classroom to PhDs. They are committed to working with the NHS, academia and other healthcare organisations to improve the delivery of healthcare and achieve the best health outcomes for people in the UK.
The role will be based at our clients' site in Tadworth, Surrey. Tadworth is a large suburban village in Surrey in the south-east of the Epsom Downs, part of the North Downs.
The Clinical Document 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.
Key responsibilities include:
- 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 is scientifically and clinically valid.
- Review tasks including both point-to-point data checks pressure value that satisfies study inclusion criteria and interpretive analysis.
- 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.
To be considered for the role, you should have the following key experiences, skills and qualifications:
- Bachelor's degree in one of the disciplines related to life sciences, drug development or business.
- Advanced degree is desirable.
- Prior 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.
For more information or to apply for this position, please contact Jenni Woolley on 01438 768 710 or email email@example.com. Alternatively, please click on the link below to apply online now. 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 45793 in all correspondence.