TMF Specialist (All Levels)
Job Description
TMF Specialist - India, Chennai Hybrid: Office-based
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply