Associate Director of Clinical Operations

Job Summary

To support a leading clinical research organization, the remote Associate Director of Clinical Operations will manage TMF strategy, governance, and operational execution across multiple clinical trial programs, ensuring compliance and inspection readiness.

Key responsibilities

• Lead TMF strategy and operational execution across clinical trial programs, ensuring compliance with ICH-GCP and FDA regulations
• Oversee TMF quality, completeness, accuracy, and timeliness while developing and maintaining TMF plans and controlled documentation
• Provide leadership to Clinical Operations Managers and TMF Specialists, driving process improvement initiatives and supporting regulatory interactions

Required qualifications

• Bachelor's degree in Life Sciences, Clinical Research, or related field; advanced degree preferred
• 10+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments with leadership responsibilities
• 6+ years of experience managing TMF strategy and operations
• Expert knowledge of ICH-GCP, FDA regulations, and TMF best practices
• Hands-on experience with Veeva Vault TMF and developing TMF plans and SOPs