Site File Admin - Bengaluru, India - IQVIA

IQVIA
IQVIA
Verified Company
Bengaluru, India

3 weeks ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description
Uploading reviewed and approved documents in eTMF via iTMF

  • Resolving queries and following up with CRAs / SSUS/ SFAs as per need
  • Responsible for maintaining and improving the compliance of eTMF filing
  • May support SFA 1&2 in some additional task as per need
Attending transition meetings for handover of sites from SSUS along with CRAs

  • Attending monthly calls with site CRAs to resolve action items (AIs) and other queries
  • Reviewing and resolving queries for site related documents sent by SSU/CRA (post GLP
approval) for assigned studies till Close Out

  • Customizing/completing & maintaining required site-specific trackers/templates
throughout the project lifecycle till Close out
cRSU APAC SFO - Version 1.0 Dated 02 Apr 2021

  • Conduct periodic review of site files and other applicable trackers/templates including
File Review Plan as per applicable TMF plan

  • Generate and review compliance reports (eg. TMF, IL2, AI etc.) and take necessary actions
keeping the Lead SFA and/or SFO LM involved
7. eTMF filing of documents if needed

  • Responsible for maintaining and improving overall quality (as per GCP, Country/Study
requirements and SOPs), delivery and compliance of documents sent to SFO for review
and upload for the assigned studies

  • Participates/supports in audits as needed
  • SFA - May act as SME and can get involved in delivering trainings
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