Clinical Data Risk Manager
Core
Lead Risk-Based Quality Management (RBQM) activities across clinical studies to ensure trial quality, patient safety, and data integrity.
Role type
Senior Clinical Data Risk Manager
Builds
Risk assessments, RBQM plans, signal/trend reports, and mitigation strategies for clinical trials
Domain
Clinical research / Pharmaceutical
Required skills
RBQM implementation, centralized monitoring, risk assessment, CAPA management, regulatory compliance (ICH E6/E8, 21 CFR Part 11), cross-functional leadership, data analytics
Preferred skills
Health-related degree, drug development process knowledge, RBQM platform familiarity
Technologies
RBQM platforms, clinical systems, data analytics tools
Responsibilities
Implement and coordinate RBQM procedures; review protocols and develop Study Risk Assessments; lead cross-functional risk meetings; conduct periodic centralized monitoring; lead risk review discussions and root cause analysis; ensure CAPA documentation and effectiveness; prepare signal and trend reports; maintain RBQM documentation for audits; provide line management to junior staff
Seniority
Senior, hands-on IC with management responsibilities