TMF Specialist I

Overview

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 I 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 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.
• Competent computer skills.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.