Job Description

Senior TMF Specialist - India, Chennai Hybrid: Office-based
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Senior TMF Specialist to join our diverse and dynamic team. As a Senior TMF Specialist at ICON, you will play a pivotal role in managing the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements and contributing to the advancement of innovative treatments and therapies.
What you will be doing

• o Perform a comprehensive eTMF completeness check/ periodic or milestone review and focus on cross checks, co-dependency checks and identify missing documents in Veeva Vault.

• Ensure eTMF is inspection ready for allocated studies.
• Conduct completeness check and update the expected document list (EDL) as on when required.
• Candidate would have good document knowledge to identify missing documents.
• Perform ALCOEA and metadata check to ensure accuracy and compliance.
• Collaborate with study team and TMF Lead to collect the initial requirements for review.
• Follow-up with study team and close the action items.
• Conduct training for internal team and ensure team queries are addressed.
• Follow standard SLA and deliverables are meet as per agreement with the stakeholders.

Your profile

• Bachelor's degree in a scientific or related field; advanced degree preferred.

• Minimum of 7 years of experience in TMF and periodic review.

• Should have 2-3 years' experience which involves in the missing documents identification.

• Having Veeva Vault experience and excel knowledge is added advantage.

• Strong understanding of TMF regulations, guidelines, and best practices.

• Proficiency in electronic document management systems and TMF software.

• Excellent organizational, communication, and attention to detail skills.

What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click to apply

Skills Required