Associate Director, Clinical Data Management
Core
Lead data manager for Phase 2/3 clinical studies, overseeing study-level data management from start-up through database lock, managing CROs, and ensuring data quality and compliance.
Role type
Senior IC clinical data management lead
Builds
High-quality clinical study data for pharmaceutical/biotech programs
Domain
Clinical trials / Pharmaceutical R&D
Deliverable
production ML models
Required skills
Clinical data management, CRO/vendor management, Medidata Rave EDC, database design, query management, ICH-GCP compliance, risk management, project management
Preferred skills
COPD/respiratory therapeutic area experience, small biotech environment experience, global Phase 3 study experience, CDISC standards, risk-based data review
Technologies
Medidata Rave EDC, eCOA, RTSM
Responsibilities
Develop and maintain study-specific data management strategies and timelines; oversee CRO and vendor data management activities; review and approve key data management documents (DMPs, DVPs, edit checks); lead data review, query management, and database lock; monitor data quality and study metrics; partner with cross-functional teams (Clinical Ops, Biostats, Medical Monitoring); contribute to inspection readiness and regulatory compliance.
Seniority
Senior, hands-on IC
