Risk Management Manager

Job Summary

Coordinating cross-functional risk management and central monitoring activities for assigned clinical trials, the full-time Risk Management Manager will ensure adherence to ICH GCP guidelines while focusing on quality and consistency within programs, working remotely.

Key responsibilities:

• Oversee all Risk Based Quality Management activities and develop the Central Monitoring Plan for assigned studies
• Deliver training on RBQM strategies, including risk assessment and centralized monitoring, to study teams
• Maintain the Risk Library and ensure compliance with risk assessments and centralized monitoring scope throughout the trial

Required qualifications:

• BSc/RN or equivalent combination of knowledge, skills, and experience
• At least 5 years of experience in clinical research and 3 years in Risk Based Monitoring
• Prior experience in Central Monitoring and as a Risk Manager
• Demonstrated ability to lead teams and align project milestones in a global environment
• Strong analytical skills to assess complex data and identify potential risks