South San Francisco
about 2 months ago
Manage the planning, implementation, and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management.
Represent data management on study teams, providing accurate study status and timelines, and proactively communicating data management risks.
Manage/oversee EDC database builds including CRF design, edit check specifications, and validation of the clinical database.
Manage/oversee CRF completion guidelines, data management plan, data review plan, and data transfer agreements with vendors (e.g., clinical laboratories, imaging vendors) etc. to ensure a high quality of data and compliance with applicable industry regulations and standards.
BSc life science, computer science or equivalent relevant degree.
Familiar with major EDC systems.
Knowledge of GCP, CDASH/CDISC.
10+ years of experience in Data Management for Pharmaceutical/ biotech/ CRO.
Experience managing CROs is preferred
If this sounds of interest, please reach out to me at 01737 236729 /