Manager, TMF Operations

Manager - TMF Operations, Chennai - Office based 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 Manager, TMF Operations to join our diverse and dynamic
team. As a Manager of TMF Operations at ICON, you will oversee the management,
maintenance, and compliance of the Trial Master File (TMF) for clinical research
studies. You will lead a team responsible for ensuring that all TMF
documentation is accurate, complete, and meets regulatory requirements, playing
a critical role in supporting the successful execution of clinical trials. What
You Will Be Doing: Managing the TMF Operations team responsible for maintaining
the Trial Master File (TMF) across multiple clinical studies, ensuring
compliance with GCP and regulatory requirements. Overseeing the collection,
review, and filing of essential documents, ensuring timely and accurate updates
to the TMF throughout the clinical trial lifecycle. Collaborating with
cross-functional teams, including clinical operations, regulatory affairs, and
quality assurance, to ensure TMF completeness and readiness for audits and
inspections. Developing and implementing TMF management strategies, policies,
and procedures to improve efficiency and ensure adherence to industry standards.
Monitoring TMF quality metrics, identifying areas for improvement, and driving
continuous process enhancements. Providing leadership and training to TMF staff,
fostering a culture of quality and compliance within the team. Ensuring
readiness of TMF for regulatory audits and client inspections, addressing any
findings or gaps in documentation as needed. Your Profile: Bachelor’s degree in
life sciences, clinical research, or a related field. Advanced degree or
certification in clinical operations or document management is a plus. Extensive
experience in TMF management or clinical operations within the pharmaceutical or
clinical research industry. Strong understanding of GCP, ICH guidelines, and
global regulatory requirements related to TMF management and clinical trial
documentation. Proven leadership skills, with experience managing and developing
teams in a fast-paced, regulated environment. Excellent organizational and
project management skills, with the ability to oversee multiple clinical studies
and maintain high standards of documentation. Strong communication and
interpersonal skills, with experience collaborating with cross-functional teams
and external stakeholders. Proficiency in electronic TMF systems and document
management tools, with a focus on maintaining regulatory compliance and audit
readiness. 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 excited to connect with
talented individuals. Register to our Talent Community to receive updates on
roles that align with your career goals.