Senior TMF Specialist

Senior TMF Specialist - India, Chennai - Office Based - 5+ years of TMF experience; must include 2+ years of experience in periodic file review with co-dependency checks, cross checks and identification of missing documents.

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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:

• 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 5 years of experience in TMF and periodic review.
• Must have 2-3 years’ experience which involves codependency checks, cross checks and identification of missing documents.
• 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.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply