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 strategic guidance, delivering training, mentoring study teams, and representing TMF Operations on cross-functional initiatives.
• Analyze TMF performance metrics and vendor quality outputs to identify trends, recommend process improvements, and strengthen operational effectiveness across the development program.
• Foster a culture of TMF excellence through knowledge sharing, lessons learned, and implementation of innovative approaches to improve TMF quality and efficiency

Education, Experience & Skills Requirements

Minimum Education requirement: University degree qualified or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related degree or more than 8 years extensive experience in similar roles and proven track record; direct industry experience in lieu of education will be considered

Experience & Skills:

• 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience supporting global clinical trials
• Understanding of the drug development life cycle
• Experience in handling clinical trial-related documents required
• Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents
• Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices
• Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment
• Excellent organizational skills and possess high standards and great attention to detail
• Strong communication skills – verbal and written
• Highly conscientious and takes initiative to efficiently resolve issues
• Must be resourceful and adaptable to support multiple competing demands and changing priorities
• Proven successes in problem-solving, strong decision-making, critical thinking, and conflict management
• Must be proficient in Microsoft Excel, Word, and PowerPoint, and familiar with Smartsheet and SharePoint

Other:

• Travel - Remote candidates must be willing to travel for company meetings for a minimum of one week per quarter; travel for team and/or study meetings may be required
• Role level will be filled commensurate with experience