Jobs Companies Excelya Clinical Study Assistant

Sobre este puesto de Clinical Study Assistant en Excelya

Excelya · Presencial · Leuven, Flanders, Belgium

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 Trial Assistant (CTA) supports the planning and execution of Phase 1/2 clinical trials across multiple countries by providing operational, administrative, and logistical assistance. Working closely with the Project Director and clinical study leaders, the CTA helps ensure smooth study coordination, high-quality documentation, and effective communication with CROs and external vendors in a fast-paced biotech setting, and reports directly to the Project Director.

Main Responsibilities:

  • Supports daily clinical trial execution and logistics
  • Organizes team meetings and cross-functional coordination
  • Maintains Trial Master File (TMF) quality and completeness
  • Manages essential study and regulatory documents
  • Supports study start-up and vendor/CRO coordination
  • Assists with contracts, work orders, and purchase orders
  • Ensures effective communication and tracks key updates/decisions

Requirements

  • Bachelor in life sciences, nursing or pharmacy (or equivalent)
  • Up to date in ICH-GCP guidelines
  • 2-5 years in clinical research (CTA, study coordinator, clinical research coordinator, Junior CRA)
  • Experience in biotech environment is a plus
  • Strong coordination, planning skills, TMF and documentation skills
  • Fluent in English (including writing)

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.

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Sobre Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.

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