Risk Management Specialist

Job Summary

Supporting clinical trial teams remotely, the contract Risk Based Quality Management (RBQM) Specialist will design, monitor, and execute RBQM strategies while leading the development of Risk Assessment & Mitigation Plans and performing centralized monitoring to ensure data integrity and trial quality.

Key responsibilities

• Design and execute RBQM strategies across clinical studies from startup to closeout
• Lead the development of Risk Assessment & Mitigation Plans and monitor Key Risk Indicators (KRIs)
• Train stakeholders on RBQM methodologies and collaborate with Clinical Trial Teams (CTTs) to address identified risks

Required qualifications

• Bachelor's degree with 8+ years of experience in biotech/pharma industries
• Strong experience with RBQM frameworks and execution in clinical trials
• Hands-on experience with KRIs, PQTLs, and centralized monitoring systems
• Familiarity with clinical trial operations or data management processes
• Knowledge of ICH-GCP (E6 R3, E8 R1) guidelines