Clinical Study Leader at Excelya in Leuven, Flemish Brabant, Belgium

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.

The Clinical Study Leader (CSL) oversees the operational execution of Phase 1/2 clinical trials across multiple countries, ensuring delivery on time, within budget, and to quality standards. Acting as the main operational contact, the CSL works closely with CROs, vendors, and reports to the Project Director.

Main Responsibilities:

• Lead and coordinate the cross-functional clinical study team

• Ensure on-time delivery of key study milestones

• Monitor study progress, identify risks, and drive mitigation actions

• Ensure compliance with protocol, ICH-GCP, and regulatory requirements

• Act as main sponsor contact and oversee CRO performance

• Manage external vendors, including deliverables and issue resolution

• Contribute to study planning and development of key documents

• Ensure study start readiness (sites, systems, supplies) and track budget/resources

• Maintain clear communication, escalate issues, and ensure quality and inspection readiness

• 5-8 years of experience in clinical operations (Study Lead, Senior CRA, or similar)

• Experience in early-phase clinical trials preferred

• Strong background in CRO-led studies and vendor management

• Excellent organizational, communication, and execution skills

• Pragmatic, hands-on, and solution-oriented mindset

• Ability to proactively identify and mitigate risks

• Strong stakeholder management skills

• Fluent in English

Why Join Us?

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.