Job Title: TMF Specialist (All Levels)
Company: ICON Clinical Research
Location: Chennai / Bangalore, India
Employment Type: Full-time
Work Mode: Hybrid (Office with Flex)
Department: Trial Master File (TMF) / Clinical Document Management
Experience Required: 1–15 years of experience in Trial Master File (TMF), Clinical Document Management, or Clinical Operations support with knowledge of clinical study documentation.
Education: Bachelor’s degree in Life Sciences or a related field preferred.
Salary Package:
TMF Specialist (1–5 years): ₹4–8 LPA
Senior TMF Specialist (5–10 years): ₹8–14 LPA
Lead/Experienced TMF Specialist (10+ years): ₹14–20 LPA
(Estimated as per current market standards in India; final compensation depends on experience, skills, and interview performance.)
Key Responsibilities:
Manage Trial Master File (TMF) documentation activities according to study requirements, ICON SOPs, work instructions, and regulatory guidelines.
Process, review, scan, index, file, and archive clinical study documents.
Perform document quality checks (QC) to ensure completeness, accuracy, and compliance.
Maintain study files according to client requirements and regulatory standards.
Coordinate with study teams, TMF teams, clients, and project stakeholders.
Support document receipt, tracking, reconciliation, and archival activities.
Prepare status reports and provide updates on TMF activities.
Support client and internal audits.
Participate in document archiving activities.
Provide requested study documents to internal teams and clients.
Complete assigned TMF projects within defined timelines.
Support training activities and continuous improvement initiatives.
Required Skills:
Trial Master File (TMF) Management
Clinical Trial Documentation
Electronic Trial Master File (eTMF)
Document Management
Document Review & Quality Control
Clinical Research Documentation
Regulatory Compliance
ICH-GCP Guidelines
SOP Compliance
Audit Readiness
Stakeholder Coordination
Communication Skills
Attention to Detail
Microsoft Office Suite
Preferred Skills:
Experience with eTMF systems.
Knowledge of clinical trial lifecycle and regulatory documents.
Experience supporting global clinical studies.
Ability to coordinate with CROs, sponsors, and study teams.
Experience handling audits and inspection readiness activities.
Work Locations:
Chennai, India
Bangalore, India
Benefits:
Competitive salary and performance incentives.
Health and wellness programs.
Medical, dental, and vision benefits (as applicable).
Retirement and insurance benefits.
Learning and development programs.
Career growth opportunities within global clinical research operations.
Inclusive and collaborative work environment.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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