Clinical Trial Assistant

About the Job

As a Clinical Trial Assistant at Excelya, you will be at the forefront of clinical research, playing a crucial role in supporting the management of clinical trials. Our core values of Audacity, Care, and Energy drive us to push boundaries and create innovative solutions in the clinical landscape. This position thrives on teamwork and initiative, where every contribution counts to achieve our projects' success.

Main Responsibilities

• Support Clinical Project Managers and Clinical Research Associates (CRAs) in the administration and organization of clinical trials.
• Maintain the Trial Master File (TMF) and ensure all documents are compliant with ICH-GCP guidelines.
• Assist with the preparation and organization of study documentation, including regulatory submissions and site files.
• Coordinate study supplies and materials, ensuring timely distribution to sites.
• Utilize clinical trial management systems (CTMS) and electronic TMF systems to track trial progress and documentation.
• Schedule and facilitate meetings, prepare agendas, and track action items.
• Act as a liaison with clinical trial sites to manage queries and document submissions.
• Assist in site activation and closure, including regulatory document management.
• Manage administrative duties related to study contracts and vendor relationships.
• Ensure all clinical documentation is audit-ready and assist in inspection preparations.

About You

To be successful in the Clinical Trial Assistant role at Excelya, you possess a combination of relevant experience and a passion for clinical research.

• Experience: Experience in clinical trials or a related environment, with a strong emphasis on collaboration and adaptability.
• Skills: Solid understanding of Good Clinical Practice (GCP) and regulatory requirements. Proficiency in using CTMS and eTMF systems (e.g., Veeva Vault) is advantageous.
• Education: A degree in Life Sciences, Pharmacy, or a relevant field.
• Languages: Proficiency in both French and English is essential.

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.