BeOne Medicines Ltd is seeking a Regional Clinical Compliance Manager to oversee compliance and inspection management for global clinical activities. The ideal candidate will have extensive clinical experience, particularly in oncology, and a strong understanding of ICH-GCP guidelines
Job Summary
The Regional Clinical Compliance Manager is responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeOne Clinical activities at global, regional, country, site and/or study levels.
The Regional Clinical Compliance Manager supports timely identification of non-compliance issues and quality events, ensure appropriate escalation of those issues and events as well as potential misconduct or potential Serious Breach to relevant stakeholders.
BeOne offers a market competitive compensation package including performance-based annual bonus scheme, company shares, and in-house and external learning and development opportunities.
Matching Summary
Match Score: 85
BeOne Medicines Ltd is seeking a Regional Clinical Compliance Manager to oversee compliance and inspection management for global clinical activities. The ideal candidate will have extensive clinical experience, particularly in oncology, and a strong understanding of ICH-GCP guidelines.
Skills & Requirements
Must-have
Implement Global Clinical Compliance strategy
GCP compliance guidance and support
Support inspection readiness and hosting
Conduct Remote Site Compliance Reviews
Conduct On-Site Compliance Visits
Adhere to ICH/GCP and local regulations
Nice-to-have
Highly motivated and collaborative professionals
Passionate interest in fighting cancer
Continuous learning and development opportunities
Dynamic team of collaborative professionals
Key Requirements
Minimum 10 years of progressive experience in clinical operations roles
Minimum 6 years experience in a GCP compliance or equivalent role preferred
Experience in oncology global trials preferred
Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline