Regional Clinical Compliance Manager
BeOne Medicines
Regional Clinical Compliance Manager
BeOne is seeking a Regional Clinical Compliance Manager in the Netherlands to ensure robust oversight of clinical trial compliance at the country and site level. The role requires a risk-based approach to identify and manage compliance risks, ensuring adherence to GCP and regulatory requirements. Candidates should have a scientific or healthcare degree with at least 5 years of clinical operations experience and 4 years in GCP compliance.
Regional Clinical Compliance Manager
BeOne is seeking a Regional Clinical Compliance Manager in the Netherlands to ensure robust oversight of clinical trial compliance at the country and site level. The role requires a risk-based approach to identify and manage compliance risks, ensuring adherence to GCP and regulatory requirements. Candidates should have a scientific or healthcare degree with at least 5 years of clinical operations experience and 4 years in GCP compliance.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- Serve as the primary point of contact for country teams regarding compliance
- Provide expert guidance and interpretation of regulations and internal standards
- Analyze and confirm initial country and site-specific risks
- Communicate identified country and site trends and lessons learned with Clinical Operations
- Align with Global Clinical Compliance on the execution of the Study Health Check Plan
- Lead and support key process reviews through remote desk checks
- Identify high-risk sites using a structured, risk-based approach
- Conduct Site Compliance Visits on identified high risk sites
- Support country teams in identifying, managing, and resolving compliance issues
- Support and manage individual Corrective and Preventive Actions (CAPAs)
- Support the Regional Clinical Compliance Inspection and Audit Support team