TMF Specialist I Job in Chennai at ICON plc, India for clinical trial document management and TMF compliance roles.
About the Company
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to advancing clinical development and improving patient outcomes globally. ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical research services across all phases of development.
With a strong global presence and a reputation for operational excellence, ICON combines innovation, scientific expertise, and technology to accelerate the development of life-changing therapies. The organization is deeply committed to fostering an inclusive, diverse, and supportive workplace where employees can grow professionally while contributing to meaningful healthcare advancements. TMF Specialist I Job in Chennai at ICON plc
ICON’s culture emphasizes integrity, collaboration, and continuous learning. Employees are encouraged to bring their full selves to work, knowing their contributions directly impact global clinical research and patient safety. TMF Specialist I Job in Chennai at ICON plc
Job Details
- Job Title: TMF Specialist I
- Job Requisition ID: JR142500
- Employment Type: Full-Time
- Work Mode: Office With Flex
- Location: Chennai, India
- Remote Type: Hybrid / Flexible Office
- Industry: Clinical Research / Healthcare
- Experience Level: Entry to Early Career
Job Description
ICON plc is currently seeking a TMF Specialist I to join its diverse and dynamic clinical operations team in Chennai, India. This role is ideal for candidates looking to build or strengthen their career in clinical research documentation and Trial Master File (TMF) management.
As a TMF Specialist I, you will play a critical role in supporting TMF documentation activities in compliance with regulatory requirements, client expectations, and ICON’s internal procedures. You will gain hands-on experience with clinical trial documentation processes while working closely with cross-functional teams to ensure accuracy, completeness, and timely filing of essential documents. TMF Specialist I Job in Chennai at ICON plc
This position offers an excellent opportunity to develop a strong foundation in TMF management within a globally recognized clinical research organization. TMF Specialist I Job in Chennai at ICON plc
Key Responsibilities
- Gain familiarity with Trial Master File (TMF) documentation, structure, and regulatory requirements
- Support document management activities related to clinical trials
- Assist in maintaining accurate, complete, and inspection-ready TMFs
- Ensure compliance with client-specific requirements and ICON standard operating procedures
- File, track, and manage essential clinical trial documents within electronic TMF systems
- Collaborate with clinical operations, regulatory, quality, and project teams to ensure timely document submission
- Perform routine quality checks to identify missing, incorrect, or outdated documents
- Support TMF reconciliation activities and ongoing maintenance throughout the trial lifecycle
- Contribute to internal ICON business needs and client service deliverables related to TMF management
- Escalate TMF issues or risks to appropriate stakeholders when necessary
Skills and Qualifications
Educational Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology, or a related field
Experience Requirements
- Prior experience in clinical research, document management, or TMF operations is preferred
- Freshers with relevant education and strong interest in TMF and clinical documentation may also be considered
Required Skills
- Strong attention to detail and accuracy
- Excellent organizational and time-management skills
- Basic understanding of clinical trial processes and documentation
- Ability to follow standard operating procedures and compliance guidelines
- Good written and verbal communication skills
- Ability to work effectively in a collaborative team environment
- Willingness to learn and adapt in a fast-paced clinical research setting
TMF Specialist I Job in Chennai at ICON plc
Benefits and Perks
ICON recognizes that its success is driven by the quality and dedication of its people. The organization offers a competitive and comprehensive benefits package designed to support employee well-being, financial security, and work-life balance. TMF Specialist I Job in Chennai at ICON plc
Key Benefits Include:
- Competitive salary aligned with industry standards
- Various annual leave entitlements
- Comprehensive health insurance options for employees and eligible family members
- Competitive retirement and long-term savings plans
- Life assurance coverage
- Global Employee Assistance Programme through TELUS Health, offering 24-hour access to professional support for mental, emotional, and personal well-being
- Flexible and country-specific optional benefits such as childcare support, gym membership discounts, travel subsidies, health assessments, and more
- Hybrid and flexible work arrangements supporting work-life balance
TMF Specialist I Job in Chennai at ICON plc
Why You Should Join ICON
Joining ICON means becoming part of an organization that values innovation, inclusivity, and professional growth. Employees at ICON are empowered to take ownership of their work while receiving support from experienced leaders and global teams. TMF Specialist I Job in Chennai at ICON plc
ICON offers:
- Exposure to global clinical trials and international clients
- Strong learning and development opportunities
- Clear career progression pathways within clinical operations and TMF management
- A respectful, inclusive, and diverse work culture
- The opportunity to contribute to life-saving therapies and meaningful healthcare research
ICON strongly believes that diversity and inclusion drive better outcomes for employees, clients, and patients alike. All qualified candidates are encouraged to apply regardless of background, identity, or experience level. TMF Specialist I Job in Chennai at ICON plc
Frequently Asked Questions (FAQs)
What is a TMF Specialist I role?
A TMF Specialist I supports Trial Master File documentation and ensures clinical trial records are accurate, complete, and compliant with regulations.
Is this role suitable for freshers?
Yes, candidates with relevant educational backgrounds and strong organizational skills may apply, even with limited experience.
Is the job fully remote?
No, this role follows an Office With Flex model, offering a hybrid work arrangement.
Where is the job located?
The position is based in Chennai, India.
What are the working hours?
This is a full-time role with standard business hours, subject to project requirements.
Does ICON provide training?
Yes, ICON provides onboarding, role-specific training, and ongoing learning opportunities.
How to Apply
Applicants who may require reasonable accommodation due to a medical condition or disability are encouraged to notify ICON during the application process. TMF Specialist I Job in Chennai at ICON plc
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