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 inspections, and implementing CAPAs.
• Act as the main local contact for global stakeholders, providing progress updates, risk mitigation plans, and maintaining accurate clinical documentation and reporting.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
• 4–6 years in clinical trial management with regional/local oversight.
• Experience in Phase II–IV studies and relevant therapeutic areas.
• Strong knowledge of ICH-GCP and clinical/regulatory processes.
• Solid project management, communication, and leadership skills.
• Proficiency in CTMS/EDC/eTMF
• Fluency in English and local language(s)

Benefits

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.