Regional Clinical Compliance Manager

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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

🎯 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