ICON plc, a global leader in healthcare intelligence and clinical research, is expanding its operations in India! The company is currently hiring for three key Trial Master File (TMF) positions — TMF Lead, Senior TMF Specialist, and TMF Specialist I — all based in Chennai (Hybrid/Office-based).
If you’re passionate about clinical documentation, compliance, and digital innovation, this is your opportunity to work with one of the world’s top Contract Research Organizations (CROs).
🧠 Available Positions at ICON plc
1️⃣ TMF Lead – Chennai (Hybrid)
Experience Required: 8+ years in TMF and Clinical Documentation Management
Education: Bachelor’s in Life Sciences or related field
Key Responsibilities:
- Lead setup and maintenance of the TMF Study Specific Document List (SSDL).
- Ensure completeness, accuracy, and inspection-readiness of TMF content.
- Oversee TMF health check meetings, audits, and sponsor communications.
- Train and mentor team members on TMF best practices.
- Support cross-functional teams in document quality and compliance.
2️⃣ Senior TMF Specialist – Chennai (Hybrid)
Experience Required: Minimum 7 years in TMF operations and periodic review
Education: Bachelor’s degree in Science or related field
Responsibilities:
- Conduct TMF completeness and metadata checks in Veeva Vault.
- Perform cross-checks and co-dependency validation of essential documents.
- Support eTMF readiness for audits and regulatory inspections.
- Collaborate with TMF Leads and study teams to ensure compliance with timelines.
- Train internal teams and support continuous process improvement.
3️⃣ TMF Specialist I – Chennai (Hybrid)
Experience Required: 1 –2 years (entry-level or with some document management experience)
Education: Bachelor’s degree in Life Science or relevant field
Responsibilities:
- Support TMF documentation and data integrity processes.
- Collaborate with global clinical teams for document filing and organization.
- Ensure compliance with ICON’s standard operating procedures (SOPs).
- Gain hands-on experience in electronic TMF (eTMF) systems and clinical operations.
🎯 Qualifications Required
- Bachelor’s degree (Life Science preferred).
- Excellent communication and organizational skills.
- Experience with Veeva Vault eTMF (for senior roles).
- Strong knowledge of Good Documentation Practice (GDP) and ICH-GCP standards.
💼 Benefits of Working at ICON plc
- Competitive salary and annual performance bonuses.
- Health insurance for employees and families.
- Life assurance and retirement planning.
- Global Employee Assistance Programme (TELUS Health).
- Hybrid work flexibility and inclusive, diverse workplace culture.
- Opportunities for professional development and international exposure.
📅 How to Apply
Application Link TMF Lead – Chennai (Hybrid)
Application Link Senior TMF Specialist – Chennai (Hybrid)
Application Link TMF Specialist I – Chennai (Hybrid)
