Responsibilities
- Process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs, and regulations.
- Liaise with study teams and other TMF staff 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, including 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 the 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 the 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.
Requirements
- 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.
- Good oral and written communication skills and interpersonal skills.
- Bachelor’s Degree in Life Science preferred.
