Trial Master File (TMF) Lead – Syneos Health
Location: Hyderabad, India (Hybrid)
Job Type: Full-Time
Updated: November 10, 2025
Job ID: 25103391
Company Overview
Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and delivering high-quality outcomes. With a global presence across more than 110 countries and a workforce of over 29,000 professionals, the company partners with leading pharmaceutical and biotechnology organizations to support clinical, medical affairs, and commercial operations.
Syneos Health operates on a model that places both the customer and the patient at the center of every project. The organization emphasizes process simplification, innovation, and operational efficiency to ensure high-quality, timely, and compliant clinical trial execution.
Why Work with Syneos Health
Strong focus on professional growth, career development, and continuous learning
Supportive leadership with technical and therapeutic area training
Recognized rewards and peer appreciation programs
Inclusive “Total Self” culture promoting diversity, authenticity, and global collaboration
A workplace where individual perspectives are valued and where employees feel they belong
Role Summary: Trial Master File (TMF) Lead
The TMF Lead is responsible for end-to-end management of electronic and/or paper Trial Master Files across assigned Low to Medium complexity projects. This role ensures TMF completeness, quality, compliance, and audit readiness throughout the study lifecycle. The position involves close collaboration with cross-functional teams, project managers, quality teams, and external stakeholders.
The TMF Lead may also support Senior TMF Leads on high-complexity projects as required.
Key Responsibilities
Lead TMF operations for assigned clinical studies from project award to final TMF transfer
Develop and maintain TMF Plans in alignment with project requirements
Monitor document submissions, processing, and TMF compliance throughout the study
Coordinate and oversee Quality Control (QC) reviews for TMF content
Support internal and external audits with accurate TMF representation
Manage TMF transfers and ensure high-quality archival standards
Participate in monthly project reviews, assessing operational and financial KPIs
Ensure TMF activities align with global regulatory and sponsor requirements
Required Experience & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
2–4 years of experience in TMF Management, Clinical Operations, or Clinical Documentation
Strong understanding of TMF structure, ICH-GCP guidelines, and regulatory documentation standards
Experience with eTMF systems (such as Veeva Vault, Wingspan, or similar platforms)
Ability to work in a dynamic environment with multiple stakeholders
Strong organizational, analytical, and communication skills
Equivalent experience or education may be considered as determined by Syneos Health.
Additional Information
Tasks and responsibilities may be updated at the company’s discretion based on operational needs. Syneos Health is committed to ensuring compliance with global employment legislation and provides reasonable accommodations as required under applicable laws, including the Americans with Disabilities Act (ADA).
About Syneos Health’s Impact
Over the past five years, Syneos Health has partnered in the development of:
94% of FDA-approved novel drugs
95% of EMA-authorized products
More than 200 clinical studies across 73,000 sites and 675,000+ trial participants
Learn more at the official website: syneoshealth.com
How to Apply
Candidates with relevant or transferable skills are encouraged to apply.
Apply Now or join the Syneos Health Talent Network to stay informed about future opportunities.
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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