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Sr. Manager / Associate Director, Trial Master File (TMF) Operations Lead Remote - United States
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$200
Remote
- Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
- ML Bio Solutions is searching for an experienced TMF Operations Lead to shape the critical role for ensuring completeness and accuracy of the TMF for all BBP-418 clinical trials.
- This individual is responsible for providing expert guidance in TMF management, driving a culture of compliance and quality that aligns with ICH/GCP guidelines, regulatory requirements, and internal policies.
- Reporting to the Head of Global Clinical Operations, the TMF Operations Lead will be a member of all Study Execution Teams, reporting and assessing study activities and independently translating them into requirements for the TMF. Will act as Subject Matter Expert lead for innovation projects to enhance TMF quality assessment.
- Collaborate with GCP Quality Assurance in high-level projects, developing processes and strategies and conducting training for TMF stakeholders
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