Global 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

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.