Risk Management Quality Specialist

Job Summary

To support clinical trial teams, the contract Risk Based Quality Management (RBQM) Specialist will design, monitor, and execute RBQM strategies remotely while leading the development of risk assessment plans and performing centralized monitoring to ensure data integrity and trial quality.

Key responsibilities

• Support clinical trial teams in designing and executing RBQM strategies from startup through closeout
• Lead the development of Risk Assessment & Mitigation Plans, including Critical-to-Quality factors and Key Risk Indicators
• Perform centralized monitoring to identify trends or quality signals and partner with teams to drive mitigation actions

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 Key Risk Indicators and centralized monitoring systems
• Familiarity with clinical trial operations or data management processes
• Knowledge of ICH-GCP guidelines