Location: Hyderabad, India (Hybrid)
Shift Timing: 11:00 AM – 8:00 PM IST (Aligned with Romania Operations)
Company: Syneos Health
Job ID: 25106828
Experience Required: 2–5 years (Freshers are not eligible)
About the Company
Syneos Health is a globally established, fully integrated biopharmaceutical solutions organization that accelerates clinical development and commercialization. With a strong global footprint, the company partners with pharmaceutical, biotechnology, and medical device organizations to deliver innovative, patient-centric solutions across the drug lifecycle.
Job Overview
The TMF Lead I is responsible for managing and overseeing Trial Master File (TMF) operations for low to medium complexity clinical trials. This role ensures that all clinical trial documentation is complete, accurate, compliant, and inspection-ready throughout the study lifecycle. The position requires close collaboration with cross-functional teams, sponsors, and project stakeholders.
Key Responsibilities
Act as a TMF Subject Matter Expert (SME) in project meetings including Kick-Off, QuickStart, and Quality Finish discussions
Monitor TMF health metrics, identify risks, and implement mitigation strategies to ensure compliance
Ensure proper setup, configuration, and maintenance of studies within the eTMF system
Collaborate with Project Leads and Functional Leads to ensure timely and high-quality document submissions
Maintain TMF in an inspection-ready state aligned with regulatory expectations
Support TMF Lead II and Senior TMF Leads in project execution and documentation oversight
Participate in audits, inspections, and quality control processes
Provide actionable feedback, training, and compliance guidance to project teams
Manage TMF transfer activities including completeness checks, document finalization, QC, and client handover
Track project timelines, scope, and budget; escalate deviations and out-of-scope activities
Present TMF status, risks, and performance metrics during project review meetings
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or a related field
2–5 years of experience in TMF management, clinical documentation, or clinical operations
Hands-on experience with eTMF systems and clinical trial documentation processes
Strong understanding of ICH-GCP guidelines, regulatory compliance, and inspection readiness
Excellent stakeholder communication, coordination, and analytical skills
Preferred Skills
Experience working in global clinical trials or CRO environments
Familiarity with TMF health metrics and audit readiness frameworks
Ability to manage multiple projects and deadlines in a fast-paced environment
Why This Role Matters
Direct involvement in maintaining regulatory-compliant clinical trial documentation
Exposure to global sponsors and international clinical trial operations
Opportunity to build expertise in TMF systems, audits, and inspection readiness
Strong career progression pathway in Clinical Operations and TMF Management
Important Note for Applicants
This is a mid-level role requiring prior experience in TMF or clinical research documentation. Freshers should explore entry-level roles such as Clinical Trial Assistant (CTA), Document Specialist, or Clinical Data Coordinator before applying for TMF Lead positions.
How to Apply
Interested candidates can apply through the official careers portal of the company or explore verified global opportunities on ThePharmaDaily.com
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Australia | Uxbridge | North York | Mississauga | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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