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. #LI-KT1 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 ICON
is an award-winning workplace that enables you to make a difference to patients’
lives by being part of a world-class clinical research organisation that helps
deliver new medicines & medical devices that are benefitting patients worldwide.
You are also part of a diverse company that cares about our world and is
dedicated to conducting business more sustainably and supporting the communities
in which we live. If you’re as driven as we are, join us. You’ll be working in a
great environment, with some of the brightest and the friendliest people in the
sector, and you’ll be helping shape an industry. Didn’t find the role you were
looking for? Even if the perfect role isn’t available right now, we’re always
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