Local Clinical Project Manager
Excelya · Leuven, Flanders, BE
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environmen...
Job description
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. Main Responsibilities: - Lead country-level planning and execution of clinical trials, including site selection, initiation, monitoring, and close-out, ensuring recruitment and retention targets are met. - Manage regulatory and ethics submissions, ensuring compliance with ICH-GCP, local regulations, and sponsor requirements, and tracking approvals and amendments. - Oversee sites, CRAs, and local vendors, resolving operational issues and escalating risks when necessary. - Control country budgets and resources, support contract negotiations, and ensure financial accuracy and timely invoicing. - Ensure quality and audit readiness through regular checks, supporting inspecti...