San Francisco Bay Area
3 months ago
Exciting opportunity to join a growing biopharmaceutical company and lead a team of highly-qualified Clinical Data Managers. Reporting to the VP of Biostatistics and Data Management, this position will support clinical activities for an exciting clinical pipeline on the cutting edge of cell therapy.
- Oversee all data management activities and deliverables
- Develop and implement standards and processes related to clinical data and risk-based trial management
- Develop, review, and implement processes, policies, SOPs and associated documents as they pertain to clinical data management
- Lead hiring, recruiting, and training processes for clinical data managers
- Develop Vendor Management Plans and monitor vendor performance
- Serve as cross-functional leader and collaboroate closely with senior leadership across verticals
- BA/BS in scientific/healthcare field required
- Advanced degree (MS, PhD) strongly preferred
- 10+ years of experience in data management for the pharmaceutical/biotechnology industry
- Demonstrated knowledge of clinical and database software including Oracle, Metadata RAVE, Medrio, Veeva Vault, and SAS programming
- Demonstrated knowledge of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations
My team and I are working on a variety of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or email@example.com.