Our client, a leading international biopharma company, is currently looking for a Senior CRA / Clinical Study Manager to join their clinical operations division on a rolling 12 month contract. This is an office based role in Uxbridge (for the first 6 months), the role will be responsible for overseeing phase I oncology studies across 2-3 sites within the UK.
- Limited monitoring (Phase I)
- Involved in Phase I studies
- Provide oversight for CRO studies and check on performance, checking documentation, work with CRO's
- Demonstrate a commitment to quality in all aspects of monitoring
- Adhere to study monitoring plans and support site identification by conducting feasibility studies as needed
- Conduct Pre-study Visits for Investigative Sites
- Effectively facilitate/negotiate contracts for assigned sites within clinical subject budget as needed
- Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study
- Evaluate data query trends and interact with study team in order to improve data quality
- Assist investigative sites to achieve timely and accurate data entry and resolution of queries
- Create monitoring reports, confirmation/follow-up correspondence and telephone contacts for assigned sites
- CRO oversight
- Strong CRA experience
- The ability to hit the ground running: self motivated, independent as limited support available
- Phase I an advantage - early stage in cancer patients - 2-3 sites - very intensive
- EC submission experience
- Good communication skills
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 contact Matthew Pike on +44 (0) 207 4400 639 and send your CV to [click here] or upload to 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.