Clinical Trial Operations Specialist

Excelya; Brussel Hoofdstad; Sur place; EUR 42 000 - 64 000; Plein temps

Résumé du poste

Excelya is seeking a highly organized clinical operations professional to coordinate trials across sites and countries, ensuring regulatory compliance and timely execution.

You will manage TMF, trial documentation, study systems, and cross-functional communication, contributing to a high-quality patient journey. This role offers exposure to global studies and a collaborative, growth‑driven environment.

Qualifications

• Advanced knowledge of ICH-GCP and Good Documentation Practices.
• Experience in clinical operations and trial administration in CRO environments.
• Fluent in English and French or Dutch.
• Ability to manage multiple priorities autonomously.
• Strong teamwork and stakeholder management skills.

Responsabilités

• Coordinate and support planning, execution, and reporting of clinical trials at site and country level.
• Ensure timely preparation, collection, and maintenance of trial documentation and regulatory records.
• Maintain oversight trackers and trial management systems to support study execution and reporting.
• Support TMF quality, completeness, and compliance with applicable regulations.
• Coordinate local study activities, meetings, and communication with internal and external stakeholders.
• Facilitate collaboration between clinical teams, investigational sites, and vendors.
• Manage and track study-related supplies and operational requirements at site level.
• Ensure accurate setup, maintenance, and administration of clinical trial systems and user access.
• Monitor data quality, consistency, and completeness across trial management tools.
• Support compliance with ICH-GCP, Good Documentation Practice, SOPs, and local regulatory requirements.

Connaissances

Life sciences

Clinical operations

TMF

ICH-GCP

Stakeholder management

English + French/Dutch

Formation

Master or Bachelor degree in Life Sciences or related field

Description du poste

JoinExcelya, 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 combines operational excellence, clinical trial coordination, and regulatory compliance, playing a key role in ensuring the seamless execution of clinical studies across a global environment. Ideal for a highly organized professional passionate about clinical operations, stakeholder collaboration, and delivering high-quality trial support.

Main Responsibilities:

• Coordinate and support the planning, execution, and reporting of clinical trials at site and country level.
• Ensure timely preparation, collection, and maintenance of trial documentation and regulatory records.
• Maintain oversight trackers and trial management systems to support study execution and reporting.
• Support Trial Master File (TMF) quality, completeness, and compliance with applicable regulations.
• Coordinate local study activities, meetings, and communication with internal and external stakeholders.
• Facilitate collaboration between clinical teams, investigational sites, and vendors.
• Manage and track study-related supplies and operational requirements at site level.
• Ensure the accurate set-up, maintenance, and administration of clinical trial systems and user access.
• Monitor data quality, consistency, and completeness across trial management tools.
• Support compliance with ICH-GCP, Good Documentation Practice, SOPs, and local regulatory requirements.

Requirements

• Master or Bachelor degree in Life Sciences, Administration or related field
• Previous experience in clinical research, clinical operations, clinical trial administration in a CRO environment
• Good understanding of ICH-GCP principles and Good Documentation Practices.
• Understanding of Trial Master File (TMF) processes and clinical trial documentation requirements.
• Fluent in English and French or Dutch
• Ability to work autonomously, manage multiple priorities, and collaborate effectively in a matrix environment
• Strong teamwork and stakeholder management skills.

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 caremeans 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.