1 week ago

Regional Clinical Compliance Manager

BeOne Medicines

Netherlands

1 week ago

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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.

RemoteFull-timeMid LevelICH-GCPClinical Trial Processes

Regional Clinical Compliance Manager

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RemoteFull-timeMid LevelICH-GCP

Salary

Not specified

Work Location

Netherlands, NL

Work Model

Remote

Experience Required

5 years

Employment Type

Full-time

Experience Level

Minimum 5 years of progressive experience in clinical operations roles plus minimum 4 years’ experience in a GCP compliance or equivalent role

Core Qualifications

Technical (Must-have)

ICH-GCPClinical trial processesRegulatory guidelinesRisk assessmentRoot cause analysisCAPAMS OfficeOutlookWordExcelPowerPoint

Soft Skills

AnalyticalProblem-solvingAttention to detailQuality orientationCommunicationStakeholder managementInterpersonal skillsOrganizational skillsPrioritizationMultitaskingAbility to work independentlyTeamworkSelf-awarenessInclusivityInitiativeEntrepreneurial mindsetContinuous learningAdaptabilityResults-orientedAnalytical thinkingFinancial excellenceClarity in communication

Preferred Qualifications

Technical (Nice-to-have)

Oncology global trials experience

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

Clinical CompliancePharmaceuticalGCPRemoteNetherlandsFull-timeLegalOncologyRisk ManagementCAPA

Core Qualifications

Technical (Must-have)

ICH-GCPClinical trial processesRegulatory guidelinesRisk assessmentRoot cause analysisCAPAMS OfficeOutlookWordExcelPowerPoint

Soft Skills

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