Experteer Overview
In this role you drive proactive risk management and sustained inspection readiness for clinical trials across regional/global scopes. You will lead inspection readiness, guide clinical teams on expectations, and manage responses to inspections and audits to ensure compliant remediation. You’ll foster a proactive readiness culture and oversee complex, high-risk inspections with cross-functional collaboration. This position offers meaningful impact in oncology trials and regulatory quality.

Compensaciones / Beneficios
• Lead inspection readiness and audit support across regional/integral levels
• Guide clinical teams on inspection expectations and training
• Coordinate audit/inspection responses and remediation
• Maintain inspection-ready documentation and systems
• Develop story boards with SMEs and content creation
• Coordinate cross-functional site preparation and regulatory interactions
• Lead post-inspection/audit CAPA processes, including risk assessment and effectiveness checks




• Track CAPA closures and identify opportunities for continuous improvement

Responsabilidades
• Understanding of clinical trial processes with knowledge of ICH-GCP and regulatory guidelines
• Analytical and problem-solving skills with high attention to detail
• Excellent communication and stakeholder management skills
• Ability to influence senior stakeholders and work independently in multi-cultural settings
• Fluency in English (written and verbal)
• Bachelor’s degree with 10+ years in clinical research, clinical operations, or compliance
• Minimum 4 years’ experience in a GCP compliance or equivalent role (preferred)
• Experience in inspections and audits management, including mock inspections/mock interviews
• Up to 15-20% travel
• Experience in CAPA development and tracking
• Deep knowledge of regulatory requirements and end-to-end clinical trial processes
• Experience in oncology global trials (preferred)

Requisitos principales
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📌 Regional Clinical Compliance Inspection Manager (España)
🏢 Beigene
📍 España