Risk Management Specialist

Job Summary

To support clinical trial teams in designing and executing Risk Based Quality Management (RBQM) strategies, the contract Risk Management Specialist will work remotely, 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 the design, monitoring, and execution of RBQM strategies across studies
• Lead the development of Risk Assessment & Mitigation Plans, including Critical-to-Quality factors and monitoring strategies
• Train stakeholders on RBQM methodologies and contribute to continuous improvement initiatives

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