Clinical Trial Assistant Rare Disease

Excelya; Boulogne-Billancourt; Sur place; EUR 35 000 - 45 000; Plein temps

Résumé du poste

A leading clinical research organization is seeking a Clinical Trial Assistant in Boulogne-Billancourt to support clinical studies in oncology. The role includes managing trial documentation, assisting with project management, and ensuring compliance with clinical regulations. Candidates should have a background in Life Sciences and be fluent in French and English. Join a dynamic team dedicated to innovation and collaboration in clinical research.

Qualifications

• Proven ability to thrive in collaborative, fast-moving environments.
• Manage and update Trial Master Files (TMF / eTMF).
• Coordinate documentation and submissions related to clinical studies.

Responsabilités

• Support Clinical Project Managers and CRAs in daily management of studies.
• Maintain the Trial Master File in compliance with regulations.
• Assist with preparation and tracking of study materials.

Connaissances

Experience in collaborative environments

Managing Trial Master Files (TMF/eTMF)

Proactive in managing trackers and document flow

Fluency in French

Fluency in English

Formation

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field

Outils

Veeva Vault

Description du poste

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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Support Clinical Project Managers and CRAs in the daily management of clinical studies in oncology (Phase I-III).
• Maintain and update the Trial Master File (TMF / eTMF) in compliance with ICH-GCP and SOPs.
• Coordinate study documentation : investigator site files, regulatory binders, ethics submissions.
• Assist with preparation, distribution, and tracking of study materials and trial supplies.
• Manage internal systems such as CTMS, eTMF (e.g., Veeva Vault), and study trackers.
• Schedule meetings, draft agendas and minutes, and follow up on action items with stakeholders.
• Liaise with investigational sites to ensure timely submission of documents and resolution of queries.
• Support site activation and close-out activities, including document collection and reconciliation.
• Handle administrative tasks related to study contracts, invoices, and vendor coordination.
• Ensure audit readiness of all clinical documentation and support inspection preparation.

Requirements

About You

At Excelya, taking audacious steps is encouraged , so we're looking for individuals who are ready to grow with us and share our values.

• Experience : Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years— talent matters most to us! )
• Skills : Experience managing Trial Master Files (TMF / eTMF), preferably using platforms like Veeva Vault, Proactive in managing trackers, timelines, and document flow.
• Education : Bachelor’s degree or higher in Life Sciences, Pharmacy, Nursing, or a related field
• Languages : Fluency in French & English

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.

Clinical Trial Assistant • Boulogne-Billancourt, Île-de-France, FR