TMF Specialist

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 2-14 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.

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