Regulatory Start Up Specilaist

2 months ago


Mumbai, India IQVIA Full time

Responsibilities:

Responsibilities include but are not limited to:

  • Survey build (Key study document list): Creation of electronic survey build based off required documents needed for study.
  • Package build: Prepare and build electornic packages within our system for sites which may include essential documents, regulatory documents, etc.
  • Query Tracking process: Track queries issued by regulatory bodies within our electornic system.
  • Informed Consent Form (ICF) build: Create ICF template based on country requirements as received from affiliate.
  • Essential Document Review: Review essential documents against checklist per country regulations.
  • Completion of any other defined tranactional activities, i.e., Clinical Study Report (CSR), Trial Master File Oversight.



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