ICON plc Job Opening for TMF Specialist (All Levels)- Apply Online

ICON Full Service & Corporate Support
Regulatory Document Management
Office Based

TMF Specialist I – 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.

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

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

Why join us

Ongoing development is vital to us, and as a member of our team you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. We offer a very competitive salary and benefits package that includes an excellent recruitment plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.