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