Job Title: TMF Lead
Location: Gurugram, India (Hybrid)
Company: Syneos Health
Job ID: 25105413
Employment Type: Full-Time
Experience Required: Typically 5–8 years of experience in TMF management, clinical trial documentation, or clinical operations within the pharmaceutical, biotechnology, or CRO industry.
Job Overview
Syneos Health is seeking an experienced TMF Lead to support and oversee Trial Master File (TMF) management activities for clinical development projects. The role involves managing both electronic and paper TMF documentation across assigned studies, ensuring compliance with regulatory standards and maintaining inspection-ready documentation throughout the clinical trial lifecycle.
The TMF Lead will collaborate closely with project teams, functional leads, and sponsors to ensure timely document submission, quality control, and adherence to TMF operational processes. This position plays a key role in maintaining TMF health and supporting audit and inspection readiness for global clinical trials.
Key Responsibilities
• Participate in key project meetings such as Kick-Off Meetings, QuickStart Camps, and Quality Finish Camps as the TMF Subject Matter Expert (SME), providing status updates and guidance related to TMF activities.
• Support Senior TMF Leads and TMF Lead II on project-specific TMF management tasks and operational activities.
• Verify that clinical studies are properly configured and established within the electronic Trial Master File (eTMF) platform.
• Monitor TMF health metrics, identify potential risks or issues, and implement mitigation strategies to maintain compliance and quality.
• Provide operational support within the eTMF platform for both internal and external project stakeholders.
• Collaborate with Project Leads and Functional Leads to ensure TMF documentation is submitted accurately and on time, maintaining the TMF in an inspection-ready state.
• Develop action plans to improve document compliance and follow up on any non-compliance issues related to TMF submissions.
• Attend internal project meetings and sponsor teleconferences to provide TMF updates and address documentation requirements.
• Prepare for and participate in project-specific audits and regulatory inspections to ensure TMF readiness.
• Provide ongoing feedback to project teams on TMF health and metrics and deliver targeted retraining when trends indicate gaps in compliance.
• Coordinate timelines with project teams and TMF operations to ensure smooth execution of TMF deliverables.
Required Qualifications
• Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline.
• Experience in Trial Master File management within a pharmaceutical company, biotechnology firm, or CRO environment.
• Strong understanding of clinical trial documentation standards, ICH-GCP guidelines, and regulatory requirements.
• Hands-on experience with eTMF platforms and document management systems.
• Ability to monitor TMF metrics, manage risks, and maintain inspection-ready documentation.
• Strong communication and cross-functional collaboration skills.
• Ability to work in a fast-paced global clinical development environment.
Preferred Skills
• Experience supporting global clinical trials across multiple regions.
• Knowledge of TMF health metrics, quality control processes, and compliance monitoring.
• Familiarity with sponsor and regulatory audits.
• Strong organizational and project coordination abilities.
About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization that integrates clinical, medical affairs, and commercial capabilities to accelerate the development and delivery of therapies. With more than 29,000 employees across 110 countries, the company supports pharmaceutical and biotechnology organizations in bringing innovative treatments to patients worldwide.
Over the past five years, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, conducting studies across thousands of clinical sites and patients globally.
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