Netherlands
1 day ago
Regional Clinical Compliance Manager
BeOne Medicines
Netherlands
1 day ago
Regional Clinical Compliance Manager
Regional Clinical Compliance Manager responsible for overseeing clinical trial compliance in the Netherlands. Requires expertise in GCP, risk-based oversight, and stakeholder management. Full-time remote role with a pharmaceutical company focused on oncology.
RemoteFull-timeSeniorICH-GCPRegulatory Guidelines
Regional Clinical Compliance Manager
Regional Clinical Compliance Manager responsible for overseeing clinical trial compliance in the Netherlands. Requires expertise in GCP, risk-based oversight, and stakeholder management. Full-time remote role with a pharmaceutical company focused on oncology.
RemoteFull-timeSeniorICH-GCP
Salary
Not specified
Core Qualifications
Technical (Must-have)
ICH-GCPregulatory guidelinesclinical trial processesrisk assessmentroot cause analysisCAPAMS OfficeOutlookWordExcelPowerPoint
Soft Skills
analytical thinkingproblem-solvingattention to detailquality orientationcommunicationstakeholder managementorganizational skillsprioritizationmultitaskingindependencecollaboration
Key Responsibilities
- Serve as primary point of contact for country teams on compliance matters
- Provide expert guidance on regulations and internal standards
- Analyze and confirm country and site-specific risks
- Communicate trends and lessons learned to Clinical Operations
- Align with Global Clinical Compliance on Study Health Check Plan
- Lead process reviews through remote desk checks
- Identify high-risk sites using risk-based approach
- Conduct Site Compliance Visits on high-risk sites
- Support country teams in managing compliance issues
- Manage CAPAs including risk assessment and root cause analysis
- Support Regional Clinical Compliance Inspection and Audit Support team
Clinical ComplianceGCPOncologyPharmaceuticalRemoteNetherlandsManagerQualityRegulatory