Senior Manager, Clinical Data Management
Core
Lead data manager for clinical studies, overseeing data management activities from study start-up through database lock to ensure high data quality.
Role type
Senior Manager, Clinical Data Management
Builds
Clinical study databases and data management deliverables for pharmaceutical/biotech programs
Domain
Clinical trials, Pharmaceutical/Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management strategy, Medidata Rave EDC, database build testing, query management, external data reconciliation, ICH-GCP compliance, CRO vendor oversight, data quality metrics, study timeline management
Preferred skills
Spotfire, CDISC standards, risk-based data review, small/mid-sized biotech experience
Technologies
Medidata Rave, eCOA, RTSM, Spotfire
Responsibilities
Develop study-specific data management strategies and timelines; Review and approve data management plans and specifications; Perform hands-on oversight of EDC database builds and testing; Lead data review, query management, and database lock activities; Monitor data quality metrics and study timelines to identify risks; Partner with cross-functional teams and external vendors; Review CRO financial reports and expenses
Seniority
Senior Manager, hands-on IC with strategic oversight