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Clinical Study Leader

Excelya
CompanyExcelya
CategoryHealthcare
LocationLeuven
RemoteOn-site (inferred)
EmploymentFull-time
LevelNot stated
SalaryNot stated by the employer
Posted26 Jun 2026
Last verified6 Aug 2026
SourceEmployer ATS (workable)
Applications are handled by the employer, not by us.Apply on the employer's site →
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. 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 Requirements 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 Benefits 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.