02 ott - Prato
Beigene
Overview
In this role you support regional clinical study delivery to ensure trials run on time, within budget, and to quality standards. You collaborate with the Regional Clinical Study Manager, global teams, and site staff to coordinate feasibility, start-up, TMF, and site communications. You gain hands-on experience in clinical operations and regulatory interpretation while contributing to regional study goals. This position offers exposure to multi-country study setup, quality processes, and cross-functional collaboration in a mission-driven oncology environment.
Responsabilità Oversee multiple aspects of clinical trial conduct in the region, including feasibility, start-up, document generation/review, and participant enrollment tracking
Support regulatory interpretation and implementation of ICH guidelines within regional operations
Coordinate regional team meetings (agenda, minutes) and collaborate with regional/global study teams
Assist CRAs with monitoring visit prep and TMF filing as needed
Create and maintain regional/country SharePoint folders and ensure country/site data is up to date in systems (eTMF, CTMS)
Support system access requests and user
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