Associate Director, TMF Operations Lead

Who You Are

ML Bio Solutions is searching for an experienced TMF Operations Lead to develop and implement the strategy for ensuring completeness and accuracy of the TMF for all BBP-418 clinical trials. This individual will establish and lead the TMF strategy across the BBP-418 clinical development program, ensuring inspection readiness through proactive oversight, quality management, and cross-functional collaboration. This individual will serve as the TMF Subject Matter Expert, driving process improvements, overseeing CRO performance, and fostering a culture of TMF excellence that aligns with ICH-GCP, regulatory expectations, and company standards.

What you will do

• Lead TMF operations across assigned clinical studies, ensuring timely, complete, and inspection-ready Trial Master File documentation in compliance with ICH-GCP, regulatory requirements, and company standards.
• Establish TMF governance across the clinical development program by monitoring TMF health, quality metrics, risk assessments, and inspection readiness, and communicating key findings to study teams and leadership.
• Develop, maintain, and continuously improve TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, guidance documents, and CRO TMF Oversight Plans.
• Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely document filing, issue resolution, and consistent execution of TMF processes.
• Provide strategic oversight of CRO-managed TMF activities through performance metrics, governance meetings, quality reviews, issue escalation, and continuous improvement initiatives.
• Lead TMF inspection readiness activities, including ongoing quality reviews, health assessments, audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up.
• Identify TMF compliance risks and quality trends, develop mitigation strategies, and drive corrective and preventive actions to maintain a state of continuous inspection readiness.
• Serve as the TMF Subject Matter Expert by providing st