Risk-Based Quality Management Manager

Job Summary

Supporting the execution and continuous improvement of the Risk-Based Quality Management framework, the full-time remote Risk-Based Quality Management Manager will coordinate Integrated Quality and Risk Management Plan activities, facilitate cross-functional risk management processes, and maintain documentation to ensure consistent RBQM execution across clinical trials.

Key responsibilities

• Coordinate development and maintenance of Integrated Quality and Risk Management Plans (IQRMPs)
• Facilitate cross-functional risk review meetings and ensure action items are tracked to completion
• Support routine centralized monitoring activities and risk review preparation and meetings

Required qualifications

• Bachelor's degree in health, life sciences, or related field, or equivalent combination of education and experience
• At least 2 years of experience in clinical research, data management, or a similar role in a CRO, pharmaceutical, or healthcare setting
• Basic understanding of clinical trial operations and Good Clinical Practice (GCP)
• Experience with RBQM concepts, including KRIs and risk assessments
• Familiarity with clinical trial systems such as EDC and RBQM tools like CluePoints or Medidata