Lead TMF Specialist

Job Title : Lead TMF Specialist

Summary:

Key Responsibilities & Duties:

• As a member of staff, the employee is expected to accept and give to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 5%) domestic and/or international
• To complete activities related to document receipt and processing which may include but is not limited to:review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
• To liaise with teams and other staff in order to fulfil job responsibilities and activities and to assist in providing guidance to study teams for study file archiving activities.
• To inform the Manager of training issues, project activities, quality issues and timelines as directed.
• To provide copies of study documents to ICON or client personnel as requested.
• To participate in document archiving activities as necessary.
• 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 Document Management 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 Document Management department.
• To train new hires or conduct refresher training for existing staff and performance outliers.
• To be a mentor to Assistants and Associate and help them in achieving their goals.

Experience required

• Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
• A minimum of 5 years’ experience in eTMF In depth shown eTMF/document management/related experience

Qualification

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.
• Good verbal and written communication skills and social skills.
• Competent computer skills
• 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