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 risk assessment and mitigation efforts across studies.

Key responsibilities

• Develop 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
• Train stakeholders on RBQM methodologies and collaborate with Clinical Trial Teams and CROs on implementation

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