Regional Clinical Compliance Manager

In this role you drive clinical trial compliance at the country and site level, applying a risk-based approach to protect patient safety and data integrity. You partner with regional and global teams to ensure GCP adherence and inspection readiness, guiding country processes and issue resolution. You will shape compliant study conduct and continuous improvement through risk assessment and effective CAPA management. This is a mission-driven role in a fast-paced, multinational setting with meaningful impact in oncology.

• Act as the primary contact for GCP and study procedures for country teams
• Provide expert interpretation of regulations to ensure consistent, compliant practices
• Conduct risk-based country and site assessments and identify critical data and processes
• Communicate trends and lessons learned to drive study conduct improvements
• Align with Global Clinical Compliance on Study Health Check Plan execution at country/site level
• Lead and support desk reviews of processes and ensure alignment with Clinical Operations
• Identify high-risk sites using structured risk-based approach
• Perform Site Compliance Visits on high-risk sites
• Support issue identification, management and resolution with CAPA
• Assist Regional Clinical Compliance Inspection and Audit Support in site audits/inspections

• Understanding of clinical trial processes with thorough knowledge of ICH-GCP and regulatory guidelines
• Analytical and problem-solving skills with high attention to detail
• Excellent communication and stakeholder management skills
• Good organizational skills, able to prioritize and multitask in a multicultural, fast-paced environment

• strong communication
• stakeholder management
• attention to detail
• ICH-GCP knowledge
• GCP compliance experience
• risk-based oversight