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.
About the Job
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 Clinical Operations. 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
Implement and execute the biomarker strategy across early and late-stage clinical development studies (Phases 1 to 3).
Act as the operational biomarker expert, providing guidance to both internal teams and external stakeholders.
Oversee all operational activities related to the biomarker lifecycle, from sample collection to analysis and reporting.
Coordinate assay development and validation with external CROs to ensure readiness and timely sample testing.
Collaborate with Translational Medicine and Procurement teams to select and manage biomarker vendors.
Manage timelines, budgets, risk, and quality plans for all biomarker-related operational activities.
Ensure biomarker sample management is compliant with ICH-GCP and relevant regulatory standards.
Contribute to clinical documentation (protocols, ICFs, lab manuals) and respond to regulatory queries regarding biomarker plans.
Support site and team training on biomarker sample handling and collection procedures.
Collaborate with Translational Medicine and Data Management to review biomarker data and resolve queries or discrepancies.
About You
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
