ICON plc, a global leader in clinical research and healthcare intelligence, is currently hiring for the position of Senior TMF Specialist in Chennai, India. This opportunity is ideal for professionals with experience in Trial Master File (TMF) management, clinical documentation, and eTMF systems such as Veeva Vault.
The Senior TMF Specialist job at ICON plc focuses on ensuring that the Trial Master File (TMF) for clinical studies remains inspection-ready, compliant with regulatory standards, and complete throughout the clinical trial lifecycle.
Professionals with experience in clinical trials documentation, TMF completeness checks, ALCOEA compliance, and electronic document management systems will find this role highly relevant.
Key Responsibilities – Senior TMF Specialist
The Senior TMF Specialist at ICON plc will be responsible for managing and maintaining clinical trial documentation within the electronic Trial Master File (eTMF).
Primary responsibilities include:
- Perform comprehensive eTMF completeness checks and milestone reviews
- Conduct cross-checks and co-dependency checks within the TMF
- Identify missing clinical trial documents in Veeva Vault
- Ensure the Trial Master File is inspection-ready at all times
- Update and maintain the Expected Document List (EDL)
- Perform ALCOEA compliance checks and metadata verification
- Collaborate with study teams and TMF Leads for documentation requirements
- Follow up on missing documentation and close TMF action items
- Provide training and support to internal teams on TMF processes
- Ensure deliverables are completed according to standard SLAs and stakeholder agreements
This role plays a critical function in maintaining regulatory compliance for clinical trials and supporting the global clinical operations teams at ICON plc.
Required Qualifications
Candidates applying for the Senior TMF Specialist job at ICON plc should meet the following requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related scientific field
- Advanced degree preferred
- 4–5 years of experience in Trial Master File (TMF) management
- 2–3 years experience identifying missing documents in eTMF
- Strong knowledge of TMF regulations and clinical trial documentation
- Experience with Veeva Vault eTMF system (preferred)
- Proficiency in Microsoft Excel and electronic document management systems
- Excellent organizational and communication skills
- Strong attention to detail and regulatory compliance understanding
Preferred Skills
- Experience with clinical trial documentation management
- Knowledge of ICH-GCP guidelines and TMF reference model
- Familiarity with clinical trial inspection readiness processes
- Experience working with global CROs or clinical research organizations
Salary and Benefits
Although the official salary has not been disclosed, typical compensation for a Senior TMF Specialist in India ranges between:
₹10,00,000 – ₹16,00,000 per year (CTC)
Benefits may include:
- Health insurance coverage
- Performance bonuses
- Global CRO work exposure
- Career growth in clinical operations and TMF leadership roles
Job Location
Chennai, Tamil Nadu, India
ICON plc operates globally and provides opportunities to work on international clinical trials and regulatory projects.
How to Apply
