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:
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
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
