Interact with study Sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high-quality operationalization of clinical trials in compliance with ICH-GCP and relevant local regulations.
Compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
Assist with preparation and submission of regulatory documents to responsible authorities and Institutional Review Boards/Ethics Committees.
Responsible for set‑up, maintenance, and archival of studies in the Trial Master File (TMF) and Clinical Trial Management System (CTMS).
Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in TMF. These files must be maintained in a fashion so that they are continuously available for inspect...