Hiring: Associate Director, TMF Operations Lead Company: BridgeBio Location: United States Job Posted Time: 2026-09-10 11:47:39 Employment Type: Full-time / Remote Target Skills & Keywords : GCP, Microsoft Excel, Microsoft PowerPoint, Quality Assurance About the job Experience: •8 years extensive experience in similar roles and proven track record; direct industry experience in lieu of education will be considered •8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience supporting global clinical trials Required Skills: •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. Qualifications: •ML Bio Solutions is searching for an experienced Compensation: •$191,000 - $220,000 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!