TMF Specialist (All Levels) (ICON)

Roles and Responsibilities

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