Risk and Central Monitoring Manager

Job Summary

Coordinating cross-functional risk management and central monitoring activities for assigned clinical trials, the full-time Risk and Central Monitoring Manager will ensure adherence to ICH GCP guidelines while focusing on quality and consistency across programs in a remote setting.

Key responsibilities

• Oversee Risk-Based Quality Management (RBQM) activities and develop the Central Monitoring Plan for assigned studies
• Deliver training on RBQM strategies and facilitate the identification of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)
• Maintain the Risk Library and ensure inspection readiness for risk assessments and centralized monitoring scope

Required qualifications

• BSc/RN or equivalent combination of knowledge, skills, and experience
• At least 5 years of experience in clinical research, with a minimum of 3 years in Risk-Based Monitoring
• Prior experience in Central Monitoring and as a Risk Manager is required
• Demonstrated ability to lead teams and work effectively in a global environment
• Strong analytical skills to interpret complex data and provide insights into risk reports