Senior Clinical Data Manager
San Mateo Metro Area, CA
The Senior Clinical Data Manager will support the Data Management group from study start-up through database lock and clinical study report.
- Partner with clinical study team to create the clinical data management plan (CDMP), including CRF development, data validation specifications, data transfer specifications, and clinical listings and reports.
- Oversee interactions with outside vendors on collection, transmittal, reconciliation and transfer of study specific data.
- Vendor management and oversight of all CRO data management activities to ensure proper execution of data management plans.
- Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
- Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field
- 5 plus years of experience in the pharmaceutical or biotechnology industry
- Experience managing Clinical Research Organizations (CROs)
- Solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
- Well-rounded technical skills (EDC systems, CDM systems, etc.)
- Knowledge of industry standards (CDISC, SDTM, CDASH)