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ICON Hiring TMF Specialist (All Levels) | Chennai & Bangalore | Apply Online
🏢 ICON plc
📍 Chennai & Bangalore
📂 Trial Master File
📑 Clinical Documentation
🧪 Clinical Research
ICON plc is hiring TMF Specialists (All Levels) for its Clinical Research and Regulatory Document Management division in India. This opportunity is ideal for professionals with experience in Trial Master File (TMF), clinical documentation, study file management, quality control, inspection readiness, and clinical trial operations.
Candidates with 1–15 years of TMF experience and strong knowledge of clinical study documents are encouraged to apply.
📋 Job Overview
| Details | Information |
|---|---|
| Company | ICON plc |
| Position | TMF Specialist (All Levels) |
| Location | Chennai & Bangalore |
| Work Model | Hybrid |
| Department | Regulatory Document Management |
| Experience | 1–15 Years |
| Industry | Clinical Research / CRO |
📌 Key Responsibilities
- Process study documents according to study-specific processes, ICON SOPs, work practices, and regulations.
- Maintain Trial Master Files (TMF) and study documentation.
- Review, scan, index, file, archive, and quality check study documents.
- Coordinate with study teams and TMF staff.
- Support client services contracts and internal business requirements.
- Prepare and maintain status reports.
- Support audits and inspection readiness activities.
- Participate in document archiving and retrieval processes.
- Provide copies of study documents to sponsors and internal teams.
- Participate in project-specific and departmental initiatives.
- Support compliance with GCP and regulatory requirements.
- Handle special projects assigned by management.
🎓 Educational Qualification
- Bachelor’s Degree in Life Sciences (Preferred)
- B.Pharm
- M.Pharm
- Biotechnology
- Clinical Research
- Life Sciences
- Related Healthcare Disciplines
💼 Experience Required
- 1–15 years of Trial Master File (TMF) experience.
- Strong understanding of Clinical Study Documents.
- Experience working with Clinical Trial Documentation systems.
- Ability to coordinate with study teams, clients, and stakeholders.
- Experience supporting TMF quality and inspection readiness.
💰 Expected Salary: ₹5 LPA – ₹20+ LPA (Depending on Experience & Level)
⭐ Skills Required
- Trial Master File (TMF) Management
- Clinical Documentation
- Document Control
- Regulatory Compliance
- Inspection Readiness
- Quality Control
- Clinical Trial Documentation
- ICH-GCP Knowledge
- Communication Skills
- Stakeholder Management
- Team Collaboration
- Problem Solving
🎁 Benefits Offered by ICON
- Competitive salary and performance incentives.
- Comprehensive health insurance plans.
- Retirement planning and savings benefits.
- Life assurance coverage.
- Global Employee Assistance Programme.
- Learning and development opportunities.
- Flexible benefits depending on country policies.
- Global clinical research career growth opportunities.
- Inclusive and collaborative work culture.
📄 ATS-Friendly Resume Tips for TMF Professionals
- Use TMF Keywords: Include Trial Master File (TMF), Clinical Documentation, eTMF, Inspection Readiness, Regulatory Documentation, GCP, Clinical Trial Operations, and Quality Control.
- Highlight Document Management Experience: Mention document filing, indexing, archiving, quality review, audit support, and inspection preparation activities.
- Show Clinical Research Knowledge: Include experience with clinical trials, study documentation, sponsor interactions, CRO environments, and regulatory compliance.
- Quantify Achievements: Mention document volumes handled, studies supported, audit readiness metrics, or process improvement contributions.
- Keep Resume ATS-Friendly: Use a simple format without graphics, tables, icons, or complex designs.
💡 Interview Preparation Tips
- Understand the TMF Reference Model and essential clinical trial documents.
- Revise ICH-GCP guidelines and regulatory compliance requirements.
- Prepare examples of document management and inspection readiness activities.
- Learn TMF quality review and audit processes.
- Understand document lifecycle management.
- Practice stakeholder communication and coordination examples.
- Review common clinical trial phases and study documentation requirements.
- Be prepared to discuss TMF systems and document tracking processes.
🎯 Who Should Apply?
- B.Pharm Graduates
- M.Pharm Graduates
- Pharm.D Professionals
- Life Sciences Graduates
- Biotechnology Graduates
- Clinical Research Associates
- TMF Specialists
- Clinical Documentation Professionals
- Regulatory Documentation Professionals
- Candidates interested in Global Clinical Trial Operations
📚 Recommended Resources
📝 How to Apply
- Read the complete job description carefully.
- Update your resume with TMF and Clinical Documentation experience.
- Highlight audit readiness, TMF quality review, and regulatory compliance experience.
- Ensure your profile matches the role requirements before applying.
- Apply through the official ICON careers portal.
🚀 Apply for TMF Specialist Role
📌 Before You Apply:
Kindly read the entire job description carefully before applying. Make sure your qualifications and experience align with the role requirements. Applying thoughtfully increases your chances of being shortlisted and creates a strong professional impression.
🚀 Apply Now
Kindly read the entire job description carefully before applying. Make sure your qualifications and experience align with the role requirements. Applying thoughtfully increases your chances of being shortlisted and creates a strong professional impression.
❓ Frequently Asked Questions (FAQs)
Q1. What experience is required for this role?
ICON is hiring professionals with 1–15 years of TMF experience.
Q2. Is Life Sciences education mandatory?
A Bachelor’s Degree in Life Sciences is preferred, but related healthcare qualifications may also be considered.
Q3. Is this a remote job?
No. This role follows a Hybrid work model at ICON India locations.
Q4. What is TMF?
TMF stands for Trial Master File, which contains essential clinical trial documents required for regulatory compliance and inspection readiness.
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