Apply for ICON Hiring for Senior TMF Specialist in Chennai. Explore responsibilities, qualifications, and benefits in this detailed job post.
ICON Hiring Senior TMF Specialist in Chennai – Apply Now
ICON plc, a global leader in clinical research and healthcare intelligence, is hiring for the position of Senior TMF Specialist in Chennai, India. This is a hybrid, full-time opportunity offering a flexible office-based role. ICON is known for its commitment to innovation, diversity, and excellence in the field of clinical development. If you have strong expertise in Trial Master File (TMF) management, this role could be the perfect fit for you. ICON Hiring for Senior TMF Specialist in Chennai
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization. The company partners with pharmaceutical, biotechnology, and medical device industries to accelerate the development of new and life-changing treatments. With a strong global presence, ICON focuses on advancing healthcare through scientific innovation, data-driven insights, and operational excellence. ICON Hiring for Senior TMF Specialist in Chennai
ICON fosters an inclusive workplace that values diversity and encourages collaboration among professionals from various disciplines. The company believes that its people are the key to success and continuously invests in their development, well-being, and professional growth. ICON Hiring for Senior TMF Specialist in Chennai
Position Overview: Senior TMF Specialist
As a Senior TMF Specialist, you will play a critical role in managing the Trial Master File (TMF) throughout the lifecycle of clinical trials. You will ensure that documentation complies with regulatory standards and that the TMF remains inspection-ready at all times. ICON Hiring for Senior TMF Specialist in Chennai
Your work will contribute directly to the success of ICON’s mission — delivering quality clinical data and supporting the advancement of new medical innovations.
This position is based in Chennai, India, with an office-with-flex (hybrid) working model, offering a balance between office collaboration and remote flexibility.
Key Responsibilities
The Senior TMF Specialist will handle multiple TMF-related tasks, ensuring high standards of accuracy, compliance, and efficiency. Major responsibilities include: ICON Hiring for Senior TMF Specialist in Chennai
- Perform Comprehensive eTMF Completeness Checks: Conduct detailed periodic or milestone reviews in Veeva Vault. Identify missing documents, perform cross-checks, and verify interdependencies within TMF records.
- Ensure Inspection Readiness: Maintain the eTMF in an inspection-ready state at all times for assigned studies, meeting both internal and external regulatory expectations.
- Update Expected Document List (EDL): Regularly update and maintain the EDL to reflect study progress and document requirements.
- Identify Missing Documents: Leverage your document management expertise to detect and resolve missing or misplaced records efficiently.
- Perform ALCOA-E and Metadata Checks: Verify document authenticity, legibility, contemporaneity, and accuracy to ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines.
- Collaborate with Study Teams: Work closely with TMF Leads and cross-functional study teams to collect document requirements and address review findings.
- Follow-Up and Close Action Items: Coordinate with team members to resolve outstanding issues and ensure timely document updates.
- Conduct Training and Support: Provide TMF-related training to internal teams and address any queries to improve overall document management quality.
- Meet Service Level Agreements (SLAs): Adhere to agreed timelines, maintain high-quality deliverables, and support stakeholder satisfaction.
Candidate Profile
To qualify for this position, candidates must demonstrate strong TMF experience, regulatory understanding, and technical proficiency. The ideal profile includes: ICON Hiring for Senior TMF Specialist in Chennai
Educational Qualifications
- Bachelor’s degree in a scientific, life sciences, or related discipline is required.
- An advanced degree (Master’s or equivalent) will be an added advantage.
Experience Requirements
- Minimum 7 years of professional experience in TMF management and periodic review within clinical research.
- At least 2–3 years of experience in identifying and managing missing documents in TMF systems.
- Hands-on experience with Veeva Vault eTMF is highly desirable.
- Strong Excel skills and familiarity with electronic document management tools are preferred.
Skills and Competencies
- In-depth knowledge of TMF regulations, GCP guidelines, and documentation best practices.
- Strong attention to detail and ability to identify inconsistencies in large document sets.
- Excellent organizational and time management skills.
- Effective communication and collaboration abilities for cross-functional teamwork.
- Analytical thinking and problem-solving mindset to ensure accuracy and compliance.
Why Join ICON?
ICON believes that the success of the company depends on the success of its employees. The organization offers a supportive, inclusive, and dynamic workplace designed to nurture professional growth and innovation. ICON Hiring for Senior TMF Specialist in Chennai
Benefits of Working at ICON
- Competitive Salary Packages: Receive compensation that matches your skills and experience.
- Health and Wellness: Access a wide range of health insurance plans for you and your family.
- Retirement Planning: ICON offers competitive retirement savings plans, helping you plan your future with confidence.
- Paid Annual Leave: Enjoy various annual leave entitlements to balance personal and professional commitments.
- Work-Life Balance: The hybrid work model allows flexibility and productivity in equal measure.
- Global Employee Assistance Programme (TELUS Health): 24-hour access to a worldwide network of over 80,000 professionals supporting mental, physical, and emotional well-being.
- Additional Perks: Depending on your country, benefits may include childcare vouchers, gym memberships, health assessments, bike purchase schemes, and subsidized travel passes.
- Diversity and Inclusion: ICON promotes an inclusive culture free from discrimination and harassment, welcoming all qualified applicants regardless of background or identity.
ICON’s Commitment to Inclusion and Accessibility
ICON’s core values are built around inclusion, respect, and belonging. The organization is committed to providing an environment that values diversity and equal opportunity. Every employee is encouraged to bring their authentic self to work. ICON Hiring for Senior TMF Specialist in Chennai
ICON ensures that all qualified candidates receive fair consideration for employment regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.
If a candidate requires a reasonable accommodation due to a medical condition or disability, ICON provides accessible options throughout the hiring process.
Work Environment
The Senior TMF Specialist role in Chennai offers a hybrid environment that combines the advantages of office collaboration with the flexibility of remote work. Employees can engage with teams across global locations, contributing to cross-border projects and knowledge sharing. ICON Hiring for Senior TMF Specialist in Chennai
Career Growth at ICON
ICON believes in long-term career development and provides multiple opportunities for professional advancement. Employees receive continuous training, mentorship, and learning resources to enhance their expertise. As a Senior TMF Specialist, you can expect to collaborate on international projects, work with cutting-edge tools like Veeva Vault, and gain exposure to global clinical operations. ICON Hiring for Senior TMF Specialist in Chennai
Whether you aim to specialize in TMF management, quality oversight, or clinical documentation leadership, ICON offers a clear path for progression within the organization.
Job Details
- Job Title: Senior TMF Specialist
- Company: ICON plc
- Location: Chennai, India (Hybrid – Office with Flex)
- Employment Type: Full Time
- Job Requisition ID: JR132671
- Posted On: 30+ Days Ago
- Industry: Clinical Research / Healthcare Intelligence
How to Apply for Senior TMF Specialist at ICON
If you are passionate about clinical research and meet the above qualifications, you can apply for the Senior TMF Specialist position by visiting the ICON Careers website.
Steps to Apply:
- Visit the official ICON Careers portal: https://careers.iconplc.com
- In the search bar, type “Senior TMF Specialist – Chennai” or Job ID: JR132671.
- Review the complete job details and click on “Apply Now.”
- Log in or create an account to complete your online application.
- Upload your updated resume and submit your profile for review.
Current ICON employees can apply directly through the internal employee portal. ICON Hiring for Senior TMF Specialist in Chennai
Final Thoughts
The Senior TMF Specialist position at ICON offers a remarkable opportunity for experienced clinical documentation professionals who want to contribute to global healthcare progress. With a focus on compliance, collaboration, and continuous improvement, this role is ideal for those passionate about quality in clinical research operations. ICON Hiring for Senior TMF Specialist in Chennai
If you are ready to take the next step in your career with one of the world’s top clinical research organizations, apply today and become part of ICON’s mission to shape the future of healthcare innovation. ICON Hiring for Senior TMF Specialist in Chennai
For verified pharma job updates, visit PharmaJobHub.in – India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
