Interim Senior Clinical Data Manager
Working across a key, late phase 3 study and others in early phase, you will be responsible for vendor oversight, data quality review and overseeing data cleaning of clinical trials for this rapidly growing biopharma company.
- Exciting well-funded, entrepreneurial specialist biopharma organisation
- Rapidly growing in Europe
- Recent, key phase III data success and other earlier phase pipeline
- Central London location
- Oversight of external vendors on all aspects of Data Management
- Review and approval of vendor data management documentation, such as CCGs, Data Management Plans and Data Validation Plans
- Development of data validation specifications and collaboration with Clinical Programmers on program specifications
- Oversight of database design activities, including UAT of EDC databases
- Conducting and supporting data reviews;
- Submitting queries to vendors as needed, with follow up on query resolution.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- Bachelor’s degree in a related scientific field
- Extensive data management experience
- Experience with Medidata Rave and Oracle Clinical
- Knowledge and experience with various clinical databases and key technologies (e.g., EDC, CTMS, IVRS/IWRS, CDISC and SAS)
- Demonstrated ability and experience overseeing external vendors;
- Working knowledge of GCP, ICH and regulatory guidelines;
- Understanding of the drug development process.
- Self-sufficient and able to work with minimal oversight.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-7051
AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
This job was originally posted as www.emedcareers.com/job/960357366