Senior Trial Master File Lead
hace 1 semana
Syneos Health Clinical is seeking a highly skilled Senior Trial Master File Lead to join our team. As a key member of our Clinical Operations department, you will be responsible for ensuring the timely and accurate creation, management, and delivery of Trial Master Files (TMFs) for our clients.
Key Responsibilities- Attend Trusted Process meetings as TMF Subject Matter Expert (SME) and provide updates on TMF status and progress.
- Provide support to Senior TMF Leads with various study-specific tasks and ensure TMF documentation is submitted in a timely manner.
- Evaluate and provide recommendations on optimal TMF oversight and verify studies have been properly created and configured within the eTMF platform.
- Monitor and report on TMF Health, including identifying risks, issues, and mitigation plans for the project.
- Collaborate with the Project Lead and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality.
- Prepare and participate in project-specific audits/inspections to ensure ongoing inspection-readiness of the TMF.
- Provide regular feedback to the Project Team on TMF Health/status, including actionable metrics.
- Ensure thorough understanding of contracted scope, timeline, and budget for the TMF.
- Undergraduate Degree preferred.
- Experience in a Contract Research Organization or related field.
- Trial Master File experience preferred.
- Experience with leading/co-leading projects from award into maintenance through close-out on a global scale.
- Skills should include above-average attention to detail, critical thinking, organizational, interpersonal, and collaboration.
- Ability to perform several tasks simultaneously to meet deadlines.
Syneos Health Clinical is a leading provider of clinical development solutions. With a global presence and a team of over 29,000 employees, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
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