Company: Syneos Health
Job Title: TMF Specialist I
Location: Hyderabad, India (Hybrid Work Model)
Job Type: Full-Time
Experience Required:
Minimum 1+ year experience as an eTMF Specialist
OR
Minimum 2+ years of experience as a Clinical Research Coordinator (CRC) or within a clinical research environment
Freshers Eligible: No
Job Requisition ID: 25107822
Application Deadline: May 25, 2026
About Syneos Health
Syneos Health is a globally recognized life sciences organization providing integrated clinical, medical affairs, and commercial solutions to pharmaceutical, biotechnology, and healthcare companies worldwide. The company partners with innovators across the drug development lifecycle to accelerate clinical research and improve patient outcomes globally.
With operations spanning multiple countries and involvement in a significant percentage of FDA-approved and EMA-authorized products, Syneos Health continues to be one of the most sought-after employers in the clinical research and pharmaceutical industry.
Job Overview
Syneos Health is hiring experienced professionals for the role of TMF Specialist I in Hyderabad. This opportunity is ideal for candidates with prior experience in electronic Trial Master File (eTMF) management, clinical documentation, or clinical trial coordination.
The selected candidate will support Trial Master File operations including TMF set-up, maintenance, document quality review, indexing, compliance tracking, and TMF closeout activities while ensuring adherence to ICH-GCP guidelines and global regulatory standards.
This role offers excellent exposure to global clinical trials, regulatory documentation processes, and inspection-ready TMF management practices.
Key Responsibilities
Support Trial Master File (TMF) set-up, maintenance, reconciliation, and closeout activities
Process clinical trial documentation according to SOPs, Work Instructions, ICH-GCP guidelines, and study-specific requirements
Perform document scanning, indexing, uploading, filing, and management within electronic TMF systems
Conduct TMF quality control reviews to ensure completeness, accuracy, and compliance
Identify missing, incomplete, or overdue TMF documents through Expected Document List reviews
Ensure inspection readiness of TMF records throughout the clinical trial lifecycle
Maintain confidentiality, security, and archival compliance of study documents
Collaborate with clinical operations teams and study stakeholders to resolve documentation gaps
Support active and archived clinical studies with accurate TMF maintenance
Educational Qualifications
Candidates with the following educational backgrounds are eligible to apply:
B.Pharm
M.Pharm
B.Sc Life Sciences
M.Sc Life Sciences
BDS
Other relevant Life Sciences degrees
Required Skills & Competencies
Strong understanding of Trial Master File (TMF) processes and clinical trial documentation
Familiarity with ICH-GCP guidelines and regulatory compliance requirements
Hands-on experience with electronic TMF (eTMF) systems is highly preferred
Good knowledge of medical terminology and clinical research workflows
Strong organizational and documentation management skills
Excellent verbal and written communication abilities
Attention to detail with a strong quality-focused mindset
Ability to manage multiple priorities in a fast-paced clinical research environment
Proficiency in Microsoft Office Suite and Adobe Acrobat
Why Join Syneos Health?
Opportunity to work with one of the world’s leading clinical research organizations (CROs)
Exposure to global clinical trial documentation and regulatory operations
Career growth opportunities in Clinical Research, TMF Management, and Regulatory Operations
Collaborative and professional work culture
Hybrid work flexibility in Hyderabad
Important Note for Applicants
This position is not suitable for freshers. Candidates applying for this role should have prior hands-on experience in TMF Operations, eTMF systems, Clinical Trial Documentation, or Clinical Research Coordination.
Professionals looking to build careers in Clinical Research, TMF Operations, Regulatory Documentation, or Clinical Trial Management are encouraged to apply.
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