TMF Specialist – Syneos Health (Remote India)

Syneos Health, a leading global biopharmaceutical solutions organization, is hiring TMF Specialist II for a Remote (India) position. This is an excellent opportunity for professionals with strong experience in Trial Master File (TMF) management, clinical documentation, and eTMF Quality Control.

If you’re looking to grow in clinical operations, trial documentation, and ICH-GCP compliant record management, this role offers long-term career development with a global CRO.

🔍 Key Responsibilities

As a TMF Specialist II, you will:

• Perform TMF QC following ICH-GCP, SOPs, WIs, and study-specific processes.
• Support TMF setup, maintenance, and closure.
• Perform document scanning, indexing, filing, and verification in the electronic TMF.
• Ensure document security, compliance, and audit readiness.
• Perform quality review of submitted documents.
• Liaise with document owners to resolve discrepancies.
• Handle administrative tasks, status reports, and trackers.
• Participate in TMF reconciliation for audits/inspections.
• Maintain compliance with training, productivity, and quality metrics.
• Work independently while collaborating with global teams.

🎓 Qualifications & Requirements

• 2–3 years of hands-on TMF experience (mandatory).
• Undergraduate degree in Life Sciences/Regulatory/Scientific field preferred.
• Minimum 18 months of records management experience.
• Experience with eTMF platforms preferred.
• Knowledge of GCP, ICH, regulatory requirements, and medical terminology.
• Strong communication, organization, and time-management skills.
• Proficiency in Microsoft Office & Adobe Acrobat.
• Ability to manage multiple tasks in a fast-paced environment.

🌟 Why Join Syneos Health?

• Work in a globally recognized CRO supporting leading FDA & EMA projects
• Career advancement & structured learning
• Supportive management with a strong focus on employee well-being
• Opportunity to work on global clinical trials
• Remote flexibility within India
• Work culture aligned with the Total Self philosophy

📌 Job Details

• Job Title: TMF Specialist II
• Company: Syneos Health
• Location: Remote (India)
• Job Type: Full-time
• Posting Date: 1 December 2025
• Salary (Estimated Range): ₹6,00,000 – ₹12,00,000 per annum

📥 How to Apply

Application Link