Senior Clinical Risk Manager

Job Summary

Leading the execution of Risk-Based Quality Management (RBQM) strategies across complex clinical trials, the full-time Senior Clinical Risk Manager will collaborate with cross-functional teams and CROs to identify, assess, and mitigate risks, ensuring high-quality study delivery and compliance with global regulations in a remote capacity.

Key responsibilities

• Develop and manage study-level risk assessments and integrated Quality Risk Management Plans
• Document and escalate risks to leadership while tracking Key Risk Indicators for data-driven decision-making
• Serve as a subject matter expert for RBQM, ensuring adherence to SOPs and contributing to process enhancements

Required qualifications

• Bachelor's degree in a scientific or technical discipline or equivalent experience
• 8+ years of Clinical Operations or Development experience, with at least 7 years focused on RBQM
• Prior in-house RBQM experience at the Manager or Senior Manager level
• Strong knowledge of RBQM principles and global clinical research regulations
• Experience supporting regulatory inspections and audits related to RBQM