TMF Specialist (All Levels)

TMF Specialist - India, Chennai Hybrid: 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.

As a TMF Specialist you will complete Document Management activities in support of client services contracts and internal ICON business needs.

What you do?

• Process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable.

• Liaise with study teams and other TMF staff in order to fulfill job responsibilities and activities.

• Complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations.

• Maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations.

• Complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.

• Provide information necessary to complete client and/or departmental status reports as requested by the management of TMF department.

• Inform the Manager of training issues, project activities, quality issues and timelines as directed.

• Provide copies of study documents to ICON or client personnel as requested.

• Participate in client and/or ICON audits and document archiving activities as necessary.

• Participate in training related to fulfillment of responsibilities as required by ICON and/or the client.

• Liaise with Clients, as appropriate, on project issues when directed by the Manager.

• Handle special projects or duties as requested by the Manager.

What you need?

• Must have 1-15 years of TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents. Ability to successfully liaise with study project teams, staff, clients and management, as necessary.

• Good oral and written communication skills and interpersonal skills.

• Bachelors Degree in Life Science preferred

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

About Us

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.