Director of Clinical Trial Quality

Job Summary

To enhance clinical trial quality and risk management, the full-time remote Director of Clinical Trial Quality will design and implement quality management frameworks, oversee centralized monitoring programs, and drive continuous improvement initiatives across clinical trial processes.

Key responsibilities:

• Design and operationalize risk-based quality management frameworks for clinical trials
• Develop centralized monitoring programs to identify quality risks and trends
• Oversee quality control activities and coordinate corrective and preventive actions (CAPA)

Required qualifications:

• Bachelor's degree in life sciences, healthcare, or a related field
• 7+ years of experience in clinical research or quality management within healthcare or life sciences
• Demonstrated experience in clinical quality management and risk-based monitoring
• Experience working within regulated environments (e.g., FDA, ICH-GCP)
• Strong knowledge of clinical trial operations and regulatory requirements