Regional Clinical Compliance Manager
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Job Description
Regional Clinical Compliance Manager at BeOne overseeing clinical trial compliance in Romania. Collaborating with country teams for regulatory compliance and patient safety assurance.
Responsibilities:
- Serve as the primary point of contact for country teams regarding GCP requirements
- Analyze and confirm initial country and site-specific risks
- Communicate identified country and site trends with Clinical Operations functions
- 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
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
- Excellent English and Romanian written and verbal communication and interpersonal skills
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Benefits:
- up to 20-30% travel
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