Manager Clinical Records Mgt.
San Francisco Metro Area, California
- Develops and leads the Clinical Trial Master File (TMF) lifecycle process across functional departments and other stakeholders to drive standardization, harmonization and implementation of TMF/eTMF management and archival policy globally
- Responsible for ensuring complete and accurate TMFs through consistency and application or adoption of documented TMF procedure(s)
- Works with study vendors and CROs to ensure TMF is accurate and complete by assessing vendor TMF on an ongoing basis
- Bachelor s degree desired
- Minimum of 8 years of experience working directly with Trial Master Files and associated clinical documentation with overall 10+ years of pharmaceutical industry experience