Associate Director, Data Validation Strategy
Core
Lead the strategy and execution of integrated data review (IDR) to ensure high-quality, inspection-ready clinical data for life-changing medicines.
Role type
Senior IC clinical data management strategy lead
Builds
Integrated Data Review (IDR) operating model, standards, governance, and risk-based data review processes
Domain
Biotechnology / Pharmaceutical / Clinical Data Management
Required skills
Integrated Data Review (IDR) strategy, Risk-Based Data Management (RBDM), GxP compliance, ICH E6 (R3), ICH E8 (R1), 21 CFR Part 11, team leadership, change management, data visualization, inspection readiness
Preferred skills
AI-enabled analytics, automation, quantitative innovation
Technologies
Data review tools, analytics platforms
Responsibilities
Lead IDR strategy implementation and governance; oversee Data Review Plans (DRPs) and issue resolution; partner with Biostatistics and study teams on risk-based reviews; monitor KPIs for continuous improvement; develop SOPs and training materials; mentor the IDR team; drive automation and AI initiatives
Seniority
Senior, hands-on IC with people leadership
