Experteer Overview
In this role you ensure robust clinical trial compliance at country and site levels within an oncology-focused research landscape. You work with country, regional, and global teams to safeguard patient safety, data integrity, and inspection readiness. You apply a risk-based approach to identify and manage compliance risks and influence study conduct through expert guidance and issue resolution. This position offers meaningful impact by shaping compliance across regions and aligning with global standards.
Compensaciones / Incentivos
• Serve as the primary GCP and procedures expert for country teams
• Assess country and site risks, identify critical data and processes, and communicate trends for improvements
• Lead process reviews and remote desk checks in collaboration with Clinical Operations
• Identify high-risk sites via historical performance, recruitment feasibility, and prior non-compliances
• Conduct site compliance visits for high-risk sites on a risk-based schedule
• Support issue management and CAPA processes to ensure timely, effective corrective actions
• Assist regional teams with audit and inspection preparation and support
Responsabilidades
• Bachelor’s degree in a scientific, medical, or healthcare discipline with at least 5 years in clinical operations and 4+ years in a GCP compliance or equivalent role (or equivalent clinical operations experience)
• Strong knowledge of ICH-GCP and regulatory guidelines
• Excellent communication and stakeholder management skills
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Ability to work independently in a multi-cultural, fast-paced environment
• Experience in oncology global trials preferred