Centralized Monitoring Assistant
IQVIA RDS (india) pvt Ltd
04.2024 - Current
- Manage assigned studies with minimal provision
- Site alert/trigger management of the assigned sites of the study using CM platform
- Preparing and providing Investigational Site Pack to the site monitors for monitoring visit using CM Platform
- Hands on experience on the systems like CTMS, TMF, e-TMF, EDC, IRT etc for necessary data/tracking
- Responsible for documentation within electronic Trial Master File
- (Uploading documents, initiating signature workflow etc.) Handled access management is given TAT prioritizing urgent request
- Giving access to sites and in-house study team member to various vendor system, after verifying completeness to training compliance to SOP and filling supporting documentation
- Performing vendor access reconciliation on timely basis
- Coordinating with vendors and maintaining drugs shipment records
- Management of site payment verification associated process
- Performed monthly activity of SUSAR and e-training compliance and Drug dev LMS training follow up with CRAs
- Provided support to the study team in final Data Base Lock (DBL) activities
- Acting as a Mentor for new hires.
