To Apply for this Job Click Here
Hybrid (3 days on-site in Redwood City, CA office) 12-month contract
Responsibilities
- Lead day-to-day clinical data management activities across early- and late-stage studies, and set the data management strategy for each study
- Serve as primary liaison with CROs, EDC vendors, and third-party data vendors; review CRO proposals and oversee outsourced studies and deliverables
- Author or review CRFs and CRF completion guidelines; oversee EDC database build, UAT, maintenance, and lock/unlock
- Own Data Management Plans, study timelines, and status reporting to cross-functional teams
- Manage data cleaning and reconciliation, including query management, SAE reconciliation, external vendor data reconciliation, medical coding, and protocol deviation tracking
- Support data listings, table validation, data specifications, and data transfers ahead of statistical review and audits
- Drive data standardization across programs and contribute to SOP development and department initiatives
- Mentor and manage internal data management staff
Qualifications
- BS/BA or MS in a relevant scientific or technical field
- 11+ years of industry clinical data management experience supporting early- and/or late-stage trials
- Hands-on experience with EDC systems, clinical data standards, medical coding dictionaries (MedDRA/WHODrug), and QC/audit processes
- Working knowledge of ICH, GCP, and FDA regulations
- Proven track record of CRO and vendor oversight
- Strong leadership, communication, and cross-functional collaboration skills
- Preferred: oncology experience (solid tumors) and 5+ years of direct line management