Manager, Integrated Data Review and Quality
Core
Provide operational leadership for integrated data review activities across a clinical development portfolio to ensure inspection-ready data.
Role type
Manager, Integrated Data Review & Quality
Builds
High-quality, inspection-ready clinical data for study-level reviews
Domain
Biotechnology / Pharmaceutical Clinical Development
Required skills
Integrated Data Review, Data Quality Management, Risk-Based Data Management, Clinical Data Management, Discrepancy Management, Data Review Planning, Team Leadership, Root-Cause Analysis, ICH E6 (R3) / GxP / 21 CFR Part 11
Preferred skills
Analytics, Automation, AI-enabled solutions, Matrix organization leadership
Technologies
Listings, visualizations, dashboards, patient profiles, analytical reports, discrepancy reports
Responsibilities
Manage Integrated Data Review activities and Data Review Plans; Lead Data Review Team meetings; Review and interpret clinical, operational, safety, and external data; Manage study-level queries and discrepancies; Support database readiness and lock; Lead, coach, and develop team members; Contribute to process improvements and automation initiatives.
Seniority
Manager, hands-on IC with people management