Risk Based Quality Management Specialist

Job Summary

Supporting clinical trial teams remotely on a contract basis, the Risk Based Quality Management Specialist will design, monitor, and execute RBQM strategies while leading the development of risk assessment and mitigation plans.

Key responsibilities

• Design and execute RBQM strategies across clinical trials from startup to closeout
• Lead the development of Risk Assessment & Mitigation Plans, including Critical-to-Quality factors and Key Risk Indicators
• Perform centralized monitoring to identify trends and ensure data integrity and trial quality

Required qualifications

• Bachelor's degree with 8+ years of experience in biotech or 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