Regional clinical compliance manager

Overview

BeOne is seeking a Regional Clinical Compliance Manager to ensure robust oversight of clinical trial compliance at country and site level, applying a risk‑based approach to identify, evaluate and manage compliance risks in line with Good Clinical Practice (GCP), company procedures and regulatory requirements.

Key Responsibilities

• Serve as primary GCP subject‑matter expert for country teams, answering compliance queries and providing guidance on regulations and internal standards.
• Analyze and confirm initial country and site risks, identifying critical data and key processes.
• Communicate trends and lessons learned to Clinical Operations for continuous improvement.
• Align with Global Clinical Compliance on execution of Study Health Check Plans.
• Lead remote desk checks and, when needed, conduct site compliance visits on high‑risk sites using a structured risk‑based methodology.
• Support country teams in issue identification, management and resolution, including CAPA planning, root‑cause analysis and effectiveness assessment.
• Provide input to Regional Clinical Compliance Inspection and Audit Support team for site audits and inspections.

Core Competencies

• Deep knowledge of clinical trial processes, ICH GCP and related regulatory guidelines.
• Analytical, problem‑solving and high attention to detail.
• Excellent communication, stakeholder management and interpersonal skills in English and Italian.
• Strong organizational abilities, multitasking and independent work in multicultural settings.

Education & Experience

• Bachelor’s (or higher) degree in a scientific, medical or healthcare discipline.
• Minimum 5 years in clinical operations plus at least 4 years in GCP compliance or quality (preferred).
• Experience in global oncology trials is preferred.

Travel

Up to 20‑30 % travel, including site visits.