Maruthesh O

About Maruthesh O

As a Trial Master File Specialist at IQVIA, a leading global provider of advanced…

Experience

1. Trial Master File Specialist

   IQVIA

   Nov 2022 — Present

   Reviews documents received from sites, IRBs and CRAs to ensure compliance with GCP and IQVIA\'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.• Reviews eTMF reports on a regular basis to ensure all documents have been filed according to IQVIA SOPs.• Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.• Supports the review of site specific ICFs as changes occur during the study. Completes ICF checklists and files IRB approved ICFs throughout the study. Maintains accurate and complete site specific ICF template tracking.• Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).• Submit ongoing regulatory documents to clients as needed.• Follows the appropriate IQVIA and/or sponsor SOPs during conduct of the study.• Ensures all project documentation is appropriately filed per IQVIA SOPs, or Sponsor SOPs if required.• Provides updates to ISSC manager on a regular basis and communicates any out of scope activities.• Uploads final documents in eTMF.• Supports in creating study specific template documents, per IQVIASOP.• Performs other duties as required.

Education

• S J M College of Pharmacy

  Master's degree

  2013 — 2015