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/global 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 improvementResponsabilidades
- 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 general trials (preferred)Requisitos principales
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