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Position Name :

TMF Specialist (All Levels)

Organization :

Icon Plc

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

1 to 15 Years

Salary:

₹5.0 Lakhs to ₹18.0 Lakhs

Location:

Bangalore, Chennai

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.

Application Link

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