Job as TMF Lead at ICON "A"

Job Description

• You will be responsible to ensure a complete and accurate Trial Master File through documentation quality and consistency across programs.
• You will determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
• You will assess impact of potential changes to TMF specifications prior to implementation and collaborating with CPM if modifications are necessary.
• You will review audit reports and document metrics for trends and to ensure that program document management deliverables are on target.
• You will serve as a point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues and product defense

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