Cancer has no borders. Neither do we.
Regional Clinical Compliance Manager
Location
Germany
Posted
13 hours ago
Salary
€76.8K - €96K / year
Seniority
Lead
Job Description
Regional Clinical Compliance Manager
BeOne Medicines
• Responsible for ensuring robust oversight of clinical trial compliance at the country and site level • Apply a risk-based approach to proactively identify, evaluate, and manage compliance risks • Ensure adherence to Good Clinical Practice (GCP), company procedures, and regulatory requirements • Partner closely with country, regional and global stakeholders to safeguard patient safety, data integrity, and inspection readiness • Serve as the primary point of contact for country teams regarding GCP requirements • Analyze and confirm initial country and site-specific risks, communicate trends with Clinical Operations functions • Conduct Site Compliance Visits on identified high risk sites • Support country teams in identifying, managing, and resolving compliance issues
Job Requirements
- Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline
- Minimum of 5 years of progressive experience in clinical operations roles
- Minimum 4 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred
- Experience in oncology global trials is preferred
- Excellent English and German written and verbal communication and interpersonal skills
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Benefits
- N/A
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• Ensure robust oversight of clinical trial compliance at the country and site level • Apply a risk-based approach to proactively identify, evaluate, and manage compliance risks • Partner closely with country, regional and global stakeholders to safeguard patient safety, data integrity, and inspection readiness • Serve as the primary point of contact for country teams regarding GCP requirements • Analyze and confirm initial country and site-specific risks • Identify and manage compliance issues, providing support for Corrective and Preventive Actions (CAPAs)
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