Job Opportunity: TMF Specialist II – Remote (India)
Summary: Syneos Health is seeking a detail-oriented and experienced TMF Specialist II to join our dynamic team. In this remote role, you will be responsible for ensuring the quality and integrity of Trial Master Files (TMFs) for our clinical trials, contributing to the successful development of life-changing therapies. If you have a strong understanding of ICH-GCP guidelines, eTMF systems, and a passion for clinical documentation, we encourage you to apply. This is a great chance to accelerate your career within a leading global biopharmaceutical solutions organization.
About Syneos Health:
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job Description:
We are seeking a highly motivated and experienced TMF Specialist II to join our team in India. This remote position offers an excellent opportunity to contribute to the success of global clinical trials and advance your career in clinical operations and trial documentation. As a TMF Specialist II, you will play a crucial role in maintaining the integrity and audit readiness of our Trial Master Files (TMFs). Your primary responsibilities will include quality control of TMF documents, supporting TMF setup and maintenance, and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Perform comprehensive TMF Quality Control (QC) according to ICH-GCP guidelines, Standard Operating Procedures (SOPs), Work Instructions (WIs), and study-specific processes.
- Support the setup, maintenance, and closure of Trial Master Files (TMFs).
- Execute document scanning, indexing, filing, and verification within the electronic TMF (eTMF) system.
- Ensure the security, compliance, and audit readiness of all TMF documents.
- Conduct quality reviews of submitted documents, identifying and resolving discrepancies.
- Liaise with document owners to resolve any issues or discrepancies in a timely and efficient manner.
- Handle administrative tasks related to TMF management, including generating status reports and maintaining trackers.
- Participate in TMF reconciliation activities in preparation for audits and inspections.
- Maintain compliance with all relevant training requirements, productivity targets, and quality metrics.
- Work both independently and collaboratively within global teams to achieve project goals.
Qualifications and Requirements:
- Experience: A minimum of 2-3 years of hands-on experience in Trial Master File (TMF) management is mandatory.
- Education: An undergraduate degree in Life Sciences, Regulatory Affairs, or a related scientific field is preferred.
- Records Management: At least 18 months of experience in records management is required.
- eTMF Platforms: Experience with electronic TMF (eTMF) platforms is highly desirable.
- Regulatory Knowledge: Solid understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, regulatory requirements, and medical terminology.
- Communication Skills: Excellent written and verbal communication skills, with the ability to interact effectively with colleagues and stakeholders.
- Organizational Skills: Strong organizational and time-management skills, with the ability to prioritize tasks and meet deadlines.
- Technical Proficiency: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat.
- Adaptability: Ability to manage multiple tasks in a fast-paced and dynamic environment.
Why Join Syneos Health?
- Global Recognition: Work for a globally recognized CRO, supporting projects for leading FDA and EMA regulated pharmaceutical products.
- Career Advancement: Opportunities for career advancement and structured learning and development programs.
- Supportive Management: Supportive management team with a strong focus on employee well-being.
- Global Clinical Trials: Chance to work on exciting global clinical trials.
- Remote Flexibility: Enjoy the flexibility of working remotely within India.
- Total Self Philosophy: A work culture aligned with the Total Self philosophy, promoting work-life balance and employee well-being.
Job Details:
- Job Title: TMF Specialist II
- Company: Syneos Health
- Location: Remote (India)
- Job Type: Full-time
- Posting Date: December 1, 2025
- Salary (Estimated Range): ₹6,00,000 – ₹12,00,000 per annum (depending on experience and qualifications)
How to Apply:
Interested and qualified candidates are encouraged to apply through our online application portal. We look forward to receiving your application.