Regional Clinical Trial Management Associate
Pubblicato il 18-10-2026 - Beigene in Bolzano
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 account management for regional users
Assist in adapting global documents regionally under supervision
Contribute to regional study start-up, investigator meeting organization, and TMF country/site maintenance
Support data cleaning and follow-up of outstanding regional information
Prepare site newsletters and regional QA-related communications
Assist with regional registry data maintenance (e.g., ClinicalTrials.gov)
Provide information for Clinical Study Reports from the region
Identify operational risks and propose improvements to processes and tools
Assist in QA/audit readiness and in developing local/regional SOPs and tools
Support regional vendor setup and PO management for outsourced activities
Requisiti fondamentali
Bachelor in scientific or healthcare discipline
1+ years of experience in clinical research within biotech, pharma, or CRO
Knowledge of clinical operations methodologies and study processes
Proficiency with MS Office
Knowledge of regulations and ICH guidelines
Ability to work with regional/global stakeholders and support multiple tasks
collaboration
attention to detail
proactive problem-solving
eTMF
CTMS
TMF