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.
In this hands-on role, you will support site activation, documentation, regulatory submissions, and ensure TMF quality and inspection readiness. Working closely with cross-functional teams, you will help drive efficient study execution while maintaining full compliance with regulations and internal standards.
Main Responsibilities:
* Coordinate site activation activities and ensure all essential study documentation is collected, reviewed, and filed
* Support the site “green-light” process prior to site initiation
* Organize and prepare Site Initiation Visits (SIVs) and ensure ISF readiness
* Act as a key contact for external monitors and manage system access
* Track and support resolution of site and monitoring-related issues
* Review monitoring reports and maintain oversight of study action items
* Ensure timely follow-up and closure of site and monitor action points
* Monitor site performance, identify risks, and prepare operational reports
* Support regulatory submissions and manage distribution of study documentation
* Perform TMF reviews, support audits, and contribute to quality and process improvement initiatives
Requirements
* Bachelor’s or Master’s degree in Life Sciences or a related field
* Minimum 2 years’ experience in Clinical Research (CRA, CTA, or similar role)
* Experience in oncology clinical studies
* Solid knowledge of ICH-GCP guidelines and clinical trial regulations
* Experience with Trial Master File (TMF) management
* Strong organizational, communication, and stakeholder management skills
* Fluent in English and Dutch (French is a plus)
* Experience with diagnostic products, laboratory services, or medical devices is an asset
* Familiarity with regulatory submissions, audits, and inspection readiness
* Knowledge of clinical systems (e.g., EDC, LIMS) and ISO 13485 is a plus
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.