Job Accountabilities

• 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 inspection and completion for a...