Trial Master File (TMF) Lead – Hyderabad (Hybrid) | Syneos Health
Location: Hyderabad, India (Hybrid)
Job ID: 25103391
Updated: November 10, 2025
Position: TMF Lead
Experience Required: 4 to 7 years of experience in TMF Management or Clinical Document Management
About the Role
Syneos Health is seeking a skilled Trial Master File (TMF) Lead to manage and oversee end-to-end TMF activities across assigned clinical studies. This role supports all electronic and/or paper TMF operations from project award to final transfer, ensuring quality, compliance, and timely delivery of all documentation.
The TMF Lead will guide document processing, quality control, audit readiness, and project coordination for low to medium complexity clinical programs. The role may also support senior TMF leadership on high-complexity assignments.
Key Responsibilities
Lead and manage TMF activities for assigned projects across their lifecycle.
Develop project-specific TMF Plans aligned with sponsor and regulatory requirements.
Oversee document submission, review, classification, and filing in the eTMF system.
Coordinate Quality Control (QC) processes and manage resolution of TMF discrepancies.
Serve as the TMF representative during internal and external audits.
Ensure compliance with ICH-GCP guidelines, SOPs, and global TMF standards.
Support TMF transfer activities, archival processes, and ongoing study health checks.
Participate in monthly operational and financial project reviews.
Collaborate with cross-functional teams to maintain inspection-ready TMF status.
Provide support to TMF Lead II or Senior TMF Lead for higher-complexity studies.
Required Qualifications & Experience
Education: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field.
Experience:
Minimum 4 to 7 years of hands-on experience in TMF Management or Clinical Documentation.
Strong understanding of eTMF systems, document taxonomy, TMF reference models, and study documentation requirements.
Skills:
Thorough knowledge of GCP, ICH guidelines, and regulatory documentation standards.
Excellent organizational, analytical, and communication skills.
Ability to work in a global, fast-paced environment while ensuring high quality and accuracy.
Why Join Syneos Health?
Syneos Health is a global leader in integrated biopharmaceutical solutions, advancing clinical development with a patient-focused approach. With more than 29,000 professionals across 110 countries, the organization offers:
Comprehensive career development and growth opportunities.
Supportive and inclusive leadership culture.
Technical and therapeutic area training.
Recognition programs and competitive rewards.
A diverse environment where everyone feels valued and included.
Over the last five years, the company has collaborated on:
94% of FDA-approved novel drugs
95% of EMA-authorized products
200+ clinical studies across 73,000 sites and 675,000+ trial patients
Additional Information
This job description provides a general outline of responsibilities and qualifications. Additional duties may be assigned based on project needs. Syneos Health is committed to equal employment opportunities, reasonable accommodations, and compliance with global regulatory requirements.
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