Syneos Health Hiring for TMF Lead I for hybrid role in India requiring 5 years TMF experience and strong leadership skills.
Last Date to Apply: December 5, 2025 (10 days left)
Job Title: TMF Lead I
Company: Syneos Health
Location: Hybrid (Hyderabad, Salem, Pune, Gurugram)
Job Type: Full-Time
Mode: Hybrid
Minimum Experience: 5+ years in TMF, 2+ years as Functional Lead
Application Mode: Online
Syneos Health, a globally recognized biopharmaceutical solutions organization, is inviting applications for the position of TMF Lead I in India. Known for its integrated clinical, medical, and commercial expertise, Syneos Health partners with leading pharmaceutical and biotechnology companies worldwide to accelerate clinical trials and bring life-changing therapies to patients. Syneos Health Hiring for TMF Lead I
With a presence in more than 110 countries and over 29,000 employees, Syneos Health continues to build an environment where employees feel valued, supported, and empowered to excel. This TMF Lead I role is ideal for experienced TMF professionals who can lead inspection readiness, ensure high-quality documentation, and provide strategic oversight across global clinical studies. Syneos Health Hiring for TMF Lead I
This detailed job post covers the responsibilities, skills, qualifications, and application procedure, making it easier for job seekers to understand the role and apply confidently. Syneos Health Hiring for TMF Lead I
About Syneos Health
Syneos Health is a fully integrated organization offering clinical and commercial solutions that help biopharma companies accelerate the development and commercialization of medicines. Their Clinical Development model ensures that customers and patients remain at the center of decision-making processes. Syneos Health Hiring for TMF Lead I
The company emphasizes employee growth, supportive leadership, continuous learning, and a strong culture of belonging. With a focus on innovation, operational excellence, and collaboration, Syneos Health offers a workplace where your contributions truly matter. Syneos Health Hiring for TMF Lead I
Role Overview: TMF Lead I
The TMF Lead I is responsible for driving inspection readiness, managing Trial Master File (TMF) operations, monitoring compliance, and ensuring audit preparedness. This leadership role requires expertise in TMF governance, regulatory requirements, document management systems, and cross-functional coordination. Syneos Health Hiring for TMF Lead I
The ideal candidate should have extensive experience in TMF management, leadership capabilities, and hands-on expertise in systems like Veeva Vault TMF. Syneos Health Hiring for TMF Lead I
Key Responsibilities
1. Inspection Readiness Leadership
- Lead and maintain end-to-end TMF inspection readiness across assigned projects.
- Ensure TMF documents are continuously audit-ready through proactive oversight.
- Implement TMF governance standards, embedding inspection readiness into daily clinical operations.
- Identify, escalate, and resolve TMF issues or risks by coordinating corrective actions.
2. Strategic Oversight & Execution
- Develop TMF strategies aligned with project scope, regulatory guidelines, and timelines.
- Monitor TMF KPIs, quality metrics, and submission timelines to maintain TMF health.
- Initiate corrective/preventive actions to address documentation gaps before audits.
- Drive operational excellence across all TMF processes.
3. Cross-Functional Collaboration
- Work closely with Project Leads, Clinical Operations, Quality, and external vendors.
- Ensure timely and accurate submission of essential documents to the TMF.
- Represent TMF as a Subject Matter Expert (SME) in cross-functional forums.
- Influence strategic decisions by providing insights on TMF compliance and readiness.
4. Audit & Compliance Management
- Represent TMF Operations during internal and external audits.
- Provide expert guidance, documentation support, and real-time issue resolution.
- Lead TMF-focused meetings to review audit metrics and risk mitigation plans.
- Ensure alignment with global GCP, ICH, and regulatory requirements.
5. Training, Enablement & Continuous Improvement
- Provide TMF system training and onboarding support for stakeholders.
- Contribute to organizational initiatives aimed at improving TMF processes and quality.
- Support change management and innovation within TMF operations.
6. Additional Responsibilities
- Perform additional assigned tasks as required.
- Minimal travel up to 25% may be required.
Required Qualifications
Educational Requirement
- Bachelor’s degree in Life Sciences is mandatory.
Experience
- Minimum 5+ years of experience in TMF.
- At least 2+ years of experience as a Functional Lead.
- Experience working in global clinical trials preferred.
- Exposure to CRO environments is highly desirable.
Technical Skills
- Strong experience with Veeva Vault Trial Master File (TMF) is strongly preferred.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Understanding of clinical trial operations, regulatory compliance, and study documentation.
- Ability to manage multiple priorities and meet deadlines.
Core Competencies
- Strong leadership and stakeholder management skills.
- Critical thinking and problem-solving ability, especially with risk-based decision making.
- Strong communication, negotiation, and presentation skills.
- High attention to detail and quality-focused mindset.
- Ability to work effectively in international, cross-functional teams.
- Self-driven, adaptable, and resilient in a fast-paced environment.
Preferred Knowledge
- Understanding of Good Clinical Practice (GCP) and ICH Guidelines.
- Familiarity with financial principles related to clinical projects.
Working at Syneos Health
Working at Syneos Health gives you the opportunity to contribute to impactful clinical research efforts, collaborate with global teams, and grow professionally. The company is committed to: Syneos Health Hiring for TMF Lead I
- Career development and continuous learning
- Supportive and engaged leadership
- A strong Total Self culture where authenticity is valued
- Diversity, equity, inclusion, and belonging
- A rewarding environment with impactful work
Key Box (Highlighted Job Summary)
Position: TMF Lead I
Company: Syneos Health
Location: Hybrid (Hyderabad, Salem, Pune, Gurugram)
Experience: 5+ Years in TMF, 2+ Years as Lead
Education: Bachelor’s in Life Sciences
Skills: TMF, Veeva Vault TMF, GCP, ICH, Clinical Operations
Job Type: Full-Time Hybrid
Last Date to Apply: December 5, 2025
Industry: Clinical Research / CRO
Application Mode: Online
How to Apply
Candidates interested in the TMF Lead I position at Syneos Health can apply directly through the official company website. Syneos Health Hiring for TMF Lead I
For verified pharma job updates, visit PharmaJobHub.in – India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
