Regional Clinical Trial Management Associate

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