Apply for the ICON plc Hiring for TMF Lead Job in Chennai. Join a global clinical research leader today.
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization (CRO), recognized globally for its excellence in clinical development and data-driven healthcare solutions. Headquartered in Dublin, Ireland, ICON partners with the world’s top pharmaceutical, biotechnology, and medical device companies to accelerate the development of new therapies and improve patients’ lives. ICON plc Hiring for TMF Lead Job
The company’s reputation for innovation, integrity, and excellence is built on the expertise of its people. ICON fosters an inclusive environment that empowers individuals to deliver their best work and collaborate with others to shape the future of clinical development.
If you are an experienced professional in Trial Master File (TMF) management and want to work in a dynamic, global organization, the TMF Lead position in Chennai, India offers an exciting opportunity to build a rewarding career. ICON plc Hiring for TMF Lead Job
Job Overview: TMF Lead – India, Chennai
Job Title: TMF Lead
Location: Chennai, India (Hybrid – Office with Flex)
Employment Type: Full-time
Job Requisition ID: JR131639
Organization: ICON plc
Posted On: November 7, 2025
ICON is hiring for the position of TMF Lead to join its team in Chennai, India. The role requires a professional who can lead and manage TMF-related activities across multiple clinical trials while ensuring compliance with regulatory standards and internal quality guidelines. ICON plc Hiring for TMF Lead Job
This position offers an excellent opportunity to work in a hybrid model—balancing office collaboration and work flexibility—within a fast-paced, international environment. ICON plc Hiring for TMF Lead Job
About the Role
As a TMF Lead, you will play a vital role in ensuring that all clinical trial documentation is complete, accurate, and audit-ready throughout the study lifecycle. You will work closely with global study teams, study managers, and external partners to ensure that TMF standards and practices are implemented consistently and effectively. ICON plc Hiring for TMF Lead Job
You will also be responsible for leading study-specific TMF setup, maintaining documentation completeness, and supporting audits and inspections. The TMF Lead acts as a subject matter expert for TMF processes, ensuring data quality, compliance, and efficiency. ICON plc Hiring for TMF Lead Job
Key Responsibilities
The responsibilities of the TMF Lead include, but are not limited to, the following:
1. TMF Setup and Maintenance
- Lead the setup of the TMF Study Specific Document List (SSDL) at the start of each clinical trial.
- Ensure completeness, accuracy, and compliance of TMF content throughout all phases of the study until closeout.
- Maintain study, country, and site-level SSDLs by collaborating with all relevant functional lines (e.g., Data Management, Clinical Operations, and Regulatory Affairs).
- Conduct regular TMF quality reviews to verify that all required documentation is properly filed and indexed.
- ICON plc Hiring for TMF Lead Job
2. Process Management and Quality Control
- Monitor documentation flow and ensure that project timelines are met without compromising quality.
- Identify potential documentation delays or errors and take corrective actions proactively.
- Maintain consistency in document management practices across assigned studies and programs.
- Support the development and implementation of TMF process improvements and system enhancements.
3. Audit and Inspection Readiness
- Act as the primary point of contact for internal and external TMF audits and inspections.
- Prepare accurate audit and inspection responses in coordination with study teams.
- Ensure that the TMF is complete and compliant at the time of study closeout or submission.
4. Cross-functional Collaboration
- Facilitate effective communication between cross-functional teams from TMF setup to study closeout.
- Liaise with Data Management, Clinical, Regulatory, and other departments to ensure alignment and documentation accuracy.
- Support study teams in managing TMF activities involving external vendors.
5. Mentoring and Training
- Mentor and guide new employees in TMF management processes, standards, and systems.
- Provide training, feedback, and ongoing support to study teams to promote good documentation practices.
- Encourage continuous learning and implementation of lessons learned from previous projects.
6. Leadership and Continuous Improvement
- Lead TMF health-check meetings, sponsor interactions, and cross-team collaboration.
- Promote a culture of quality, accountability, and continuous improvement.
- Ensure ownership and accountability for TMF quality across all study teams.
Qualifications and Experience Required
The ideal candidate for the TMF Lead position should have the following qualifications and experience: ICON plc Hiring for TMF Lead Job
Education:
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or any related scientific discipline (preferred).
Experience:
- A minimum of 8 years of experience in TMF management or related roles in clinical research organizations.
- In-depth understanding of clinical study documentation and Trial Master File processes.
- Proven experience in leading TMF health check calls, managing TMF metrics, and handling sponsor queries.
Technical and Soft Skills:
- Strong knowledge of clinical research regulations (ICH-GCP, FDA, EMA).
- Proficiency in electronic TMF systems (eTMF) and documentation tools.
- Excellent communication and interpersonal skills.
- Strong organizational and problem-solving abilities.
- Ability to work independently and in cross-functional global teams.
- High attention to detail and ability to manage multiple priorities effectively.
Why Work at ICON plc?
ICON plc offers a professional environment that values innovation, collaboration, and personal growth. Working as a TMF Lead at ICON provides numerous professional and personal benefits, including: ICON plc Hiring for TMF Lead Job
1. Competitive Salary and Performance-based Bonuses
ICON ensures that its compensation packages are highly competitive within the industry. Employees also receive performance-based bonuses aligned with their achievements and organizational goals.
2. Comprehensive Health and Wellness Benefits
Employees and their families have access to a range of healthcare benefits, including medical insurance, wellness programs, and health assessments, designed to promote well-being and work-life balance.
3. Retirement and Financial Benefits
ICON provides competitive retirement plans and life assurance programs to help employees plan for their future with confidence.
4. Work-life Balance and Flexibility
The hybrid work model—Office with Flex—allows employees to balance professional and personal responsibilities while maintaining collaboration and teamwork.
5. Professional Development Opportunities
ICON emphasizes continuous learning through internal training, leadership development, and mentorship programs. The company invests heavily in skill development to help employees reach their career goals.
6. Diversity, Equity, and Inclusion
ICON is deeply committed to creating an inclusive workplace free from discrimination and harassment. The company welcomes applicants from all backgrounds and promotes equality in every aspect of employment. ICON plc Hiring for TMF Lead Job
Benefits of Working at ICON
Employees at ICON enjoy a wide variety of benefits, including: ICON plc Hiring for TMF Lead Job
- Annual leave entitlements based on local laws and company policies.
- Comprehensive health insurance options for individuals and families.
- Flexible country-specific benefits such as gym memberships, childcare vouchers, and travel subsidies.
- Access to TELUS Health Global Employee Assistance Programme, offering round-the-clock mental health and well-being support.
- Opportunities to participate in corporate wellness and community programs.
ICON’s Commitment to Inclusion and Accessibility
ICON plc firmly believes in creating an inclusive and accessible workplace. The company provides reasonable accommodations for candidates with medical conditions or disabilities throughout the application and employment process. ICON plc Hiring for TMF Lead Job
Every qualified applicant is given equal consideration regardless of race, color, religion, gender identity, sexual orientation, national origin, disability, or veteran status.
ICON encourages applications from candidates who may not meet 100% of the listed requirements but possess relevant experience and potential. ICON plc Hiring for TMF Lead Job
Key Job Details
| Job Title | TMF Lead |
|---|---|
| Location | Chennai, India (Hybrid – Office with Flex) |
| Job ID | JR131639 |
| Experience Required | Minimum 8 years in TMF or Clinical Documentation |
| Education | Bachelor’s Degree in Life Sciences (Preferred) |
| Work Type | Full-Time |
| Posted On | November 7, 2025 |
| Organization | ICON plc |
How to Apply
If you are interested in joining ICON plc as a TMF Lead, follow these steps to apply:
- Visit the official ICON careers page: https://careers.iconplc.com
- In the search bar, type “TMF Lead” or the Job ID JR131639.
- Click on the job title to view the full job description and details.
- Review the eligibility criteria and responsibilities carefully.
- Click the “Apply Now” button and complete the online application form.
- Upload your updated resume and relevant documents.
- Submit your application before the position closes.
Conclusion
The TMF Lead position at ICON plc in Chennai is an excellent opportunity for professionals with strong TMF experience to advance their careers in clinical research. As part of a global CRO, you will play a crucial role in maintaining documentation quality and ensuring regulatory compliance across multiple clinical trials. ICON plc Hiring for TMF Lead Job
ICON offers a supportive and growth-oriented environment where you can contribute to global health advancements while developing your expertise.
If you’re passionate about excellence in clinical documentation and ready to take the next step in your career, apply today and become a part of ICON’s mission to improve patient lives through data-driven innovation. ICON plc Hiring for TMF Lead Job
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