Clinical Compliance Manager
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* Provide GCP and regulatory guidance to clinical study teams
* Lead risk-based compliance assessments and prioritize activities
* Escalate significant quality issues to leadership
* Participate in CRO/vendor governance and vendor evaluations as SME
* Support CAPA development and responses to audit findings
* Coordinate quality management system activities including deviations and root cause analysis
* Lead inspection readiness and ensure training for project teams
* Collaborate with cross-functional teams to address trend-based quality improvements Requisitos principales
* Minimum 5 years in clinical operations or compliance roles (clinical trial manager, clinical project manager, etc.)
* Experience in clinical compliance, quality assurance, or regulatory compliance
* Thorough knowledge of drug development and clinical trial process
* Strong understanding of regulatory and ICH GCP requirements and international regulations
* Working knowledge of CAPA management, risk management, and regulatory inspections
* Collaborative mindset
* Stakeholder management
* Proactive problem-solving
* GCP knowledge
* ICH guidelines understanding
* CAPA management
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