Shrutika Kadam

• Conduct the Comprehensive Quality Trial Master File Review in accordance with eSOPs, Guidance Documents, File Review Overview Form and Project Instruction, when applicable.
   Review documents in line with ALCOA principles.
   Focus on cross checks, co-dependency checks and identification of missing documents.
   Identify metadata and document inaccuracies as Action Items.
   Create Action Items and assign them to users (Document Owners or self).
   Raise valid and clear action items, as per Action Item Response Table or another applicable document.
   Address Action Items assigned to self and close them in accordance with review timelines.
   Review documents within agreed timelines according to guidance documents for respective TMF platform, always complete 100% of cross checks and co-dependency check.
   Support QPM in timely delivery of the comprehensive file review cycle, proactively communicating review finalization.
   Actively communicate findings, trends, file review related questions and escalations to the QPM.
   When assigned, support other TMF related activities.
   Provide support to other TMF Specialists as Buddy or Mentor, when needed.

• Reviews documents received from sites, IRBs and CRAs to ensure compliance with GCP and Iqvia Biotech’s standard operating procedures.
  • Manages ongoing IRB/ethics continuing renewals, where applicable, and reviews investigator study files for expired documents.
  • Communicates directly with the site, or with local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents. Tracks any action items to CRAs/sites in CTMS.
  • Perform quarterly site file review to ensure all documents have been filed according to Iqvia Biotech SOPs.
  • Send MVR packet (e-TMF inventory report and Action items) to CRA before Site visit.
  • Follows the appropriate Iqvia Biotech and/or sponsor SOPs during conduct of the study.
  • Provides updates to ISSC manager on a regular basis, and communicates any out of scope activities.
  • Uploads final documents in eTMF.
  • Performs other duties as require

• Project set up and management.
• Training the study team on protocol.
• Prepare customized documents for study.
• Co-ordinate with IT team for electronic data transfer set up if applicable for the study.
• Resolving any queries from sponsor or investigator site.
• Participate in telecoms to update the sponsor of the study progress.
• Escalation of issues/complaints to the QA team.
• Ensure that the study is managed as per the SOP’s and any guidelines laid down by the sponsor.
• Appropriate archiving of study documents with necessary documentation following project close out.