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