Lead TMF Specialist

Job Title : Lead TMF Specialist

Summary:

Key Responsibilities & Duties:

• *To 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.
• *To liaise with study teams and other TMF Operations staff in order to fulfil job responsibilities and activities and to assist in providing guidance to study teams for study file archiving activities.
• *To provide information necessary to complete client and/or departmental status reports as requested by the management of the TMF Operations department.
• *To provide inputs for improvement in the process of acquiring the knowledge and skills.
• *To maintain document record and filing supplies ensuring adequate supplies are available to TMF Operations staff.
• *To manage and maintain document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the Manager.
• *To develop, compile and submit client and/or departmental status reports as requested by the management of the TMF Operations department.
• *To be a mentor to Assistants and Associate and help them in achieving their goals.
• *Collate process improvement inputs from Assistants and Associates, perform analysis, come up with solutions/methods to improve business, seek Manager’s approval for implementation, facilitate implementation, perform impact analysis and provide update to Manager.

Experience required

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
• CAN/LATAM/US: A minimum of 5 years’ experience in eTMF
• In depth proven eTMF/document management/related experience

Academic or Trade qualifications:

Benefit Working with ICON:

Process

Interview

Offer