SCOPE

Exciting opportunity to join a growing biopharmaceutical company in the San Francisco Bay Area. Reporting to the Senior Director of Data Management, this position will support clinical activities for an exciting oncology clinical pipeline.

RESPONSIBILITIES

• Oversee CROs and external vendors and review documents produced by vendors
• Review data for protocol deviation identification
• Contribute to development of SOPs and study protocols from data management perspective
• Initiate, maintain and archive data management related project documentation
• Quality check all data and resolve queries

QUALIFICATIONS

• BA/BS in scientific/healthcare field required
• Advanced degree (MS, PhD) strongly preferred
• 5+ 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  e.mato@hamlynwilliams.com.