Senior Manager, Clinical Data Management
Core
Lead clinical data management activities across studies/programs from start-up to database lock, ensuring inspection-ready data quality.
Role type
Senior Manager, Clinical Data Management
Builds
Clinical study databases (Medidata Rave), data review packages, and inspection-ready deliverables
Domain
Pharmaceutical/Biotechnology Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management strategy, Medidata Rave EDC expertise, database build testing, query management, external data reconciliation, ICH-GCP compliance, CRO/vendor management, budget oversight
Preferred skills
Spotfire, CDISC standards, risk-based data review, small/mid-sized biotech experience
Technologies
Medidata Rave, eCOA, RTSM, Spotfire
Responsibilities
Establish study-specific data management strategies and timelines; Review and approve Data Management Plans and database build documentation; Provide hands-on oversight of EDC builds, edit checks, and workflows; Plan and execute testing of database builds and UAT; Lead data review, query management, and database lock activities; Monitor data quality metrics and timelines; Partner with Clinical Operations, Biostatistics, and Medical Monitoring to ensure compliance; Review CRO financial reports and expenses; Identify opportunities to improve data management processes and standards
Seniority
Senior Manager, strategic oversight with hands-on technical execution
