Job Title: TMF Lead (Trial Master File Lead)
Location: Madhapur, Telangana, India
Job ID: 25105413
Company: Syneos Health
About the Company
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating customer success across clinical development, medical affairs, and commercialization. Operating in more than 110 countries with over 29,000 professionals, the company partners with pharmaceutical, biotechnology, and medical device organizations to bring therapies to market efficiently and compliantly.
Over the past five years, Syneos Health has supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products, demonstrating strong global clinical research and regulatory capabilities.
Job Overview
The TMF Lead (Trial Master File Lead) is responsible for managing and overseeing electronic and/or paper Trial Master File (TMF) activities for assigned clinical studies from award through final transfer and archiving. The role ensures the TMF remains complete, accurate, and inspection-ready in accordance with ICH-GCP guidelines, global regulatory standards, and company SOPs.
This position typically handles low to medium complexity clinical trials and may support senior TMF leadership on high-complexity programs.
Experience Required
Minimum 5–8 years of experience in clinical research
At least 3+ years of hands-on TMF management experience
Experience in CRO, pharmaceutical, or biotechnology environments
Practical exposure to electronic Trial Master File (eTMF) systems
Prior audit and inspection readiness experience preferred
Key Responsibilities
TMF Operations and Oversight
Manage full lifecycle TMF activities from study start-up to final transfer
Verify accurate study setup and configuration within the eTMF platform
Maintain continuous inspection readiness and overall TMF health
Develop and execute project-specific TMF Plans
Monitor document completeness, quality, and submission timelines
Project Collaboration and Stakeholder Management
Attend Kick-Off Meetings, QuickStart Camps, Quality Finish Camps, and other trusted process meetings as the TMF Subject Matter Expert
Provide regular TMF status updates and actionable metrics to stakeholders
Collaborate with Project Leads and Functional Leads to ensure timely document filing
Participate in sponsor calls and internal project meetings as required
Quality, Compliance, and Risk Management
Monitor and report TMF health metrics, identifying risks and mitigation strategies
Drive compliance improvements and follow up on non-compliance trends
Support and participate in internal and external audits and regulatory inspections
Oversee and coordinate Quality Control processes
Deliver targeted retraining to project teams based on TMF performance data
Operational Excellence
Provide timelines and deliverable tracking to project teams and TMF Operations
Support TMF Lead II or Senior TMF Leads on complex studies
Contribute to operational and financial KPI reviews
Drive continuous process improvement initiatives within TMF Operations
Technical Skills and Knowledge
Strong understanding of ICH-GCP guidelines and global regulatory frameworks including FDA and EMA requirements
Experience with industry-standard eTMF platforms
Knowledge of clinical trial documentation lifecycle management
Strong analytical and reporting capabilities related to TMF health metrics
Proficiency in Microsoft Office tools and project management systems
Core Competencies
Excellent communication and stakeholder engagement skills
Strong organizational and time management capabilities
Detail-oriented with a strong quality mindset
Ability to manage multiple concurrent projects
Strong problem-solving and risk assessment skills
Effective collaboration within global, cross-functional teams
Why Join Syneos Health
Opportunity to work on global clinical development programs
Structured career development and training opportunities
Collaborative and performance-driven environment
Exposure to multinational regulatory standards and best practices
Opportunity to contribute to therapies that improve patient lives worldwide
Equal Opportunity Statement
Syneos Health is committed to equal employment opportunity and compliance with applicable employment legislation across all regions of operation. Reasonable accommodations will be provided where required to enable individuals to perform essential job functions.
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