Clinical Trial Assistant

Excelya Group; Saclay; On-site; EUR 32,000 - 42,000; Full time

Job summary

Excelya Group is seeking a Clinical Trial Assistant to support the operational management of international clinical studies. You will work with Clinical Project Managers and CRA teams across several countries, coordinating study documentation, regulatory support, and study operations.

You will ensure eTMF and ISF accuracy, assist with submissions to authorities, and provide cross-functional team support, contributing to compliant, efficient trial delivery in a fast-paced environment.

Qualifications

• Experience with international clinical trials.
• Experience with eTMF, ISF and study documentation.
• Knowledge of ICH-GCP guidelines; certification preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Responsibilities

• Manage Sponsor Trial Master Files (eTMF) and essential study documentation with Clinical Project Managers.
• Support preparation, maintenance, and tracking of Investigator Site Files (ISF).
• Contribute to study feasibility activities and site selection processes.
• Assist with submissions to regulatory authorities and ethics committees.
• Support study start-up and site activation activities.
• Provide operational support to Clinical Project Managers and CRAs.
• Organize study meetings, draft agendas and minutes.
• Ensure documentation is complete, accurate and ICH-GCP compliant.
• Collaborate with cross-functional teams across international studies.
• Provide back-up support for other team members when required.

Skills

International trials

eTMF & ISF

ICH-GCP

Regulatory support

Cross-functional

English fluent

Tools

Microsoft Office

Job description

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

As a Clinical Trial Assistant, you will support the operational management of international clinical studies and work closely with Clinical Project Managers and CRA teams across multiple countries. You will play a key role in study coordination, documentation management, regulatory support, and clinical operations activities.

Key Responsibilities

• Manage Sponsor Trial Master Files (eTMF) and essential study documentation in collaboration with Clinical Project Managers.
• Support the preparation, maintenance, and tracking of Investigator Site Files (ISF).
• Contribute to study feasibility activities and site selection processes.
• Support the preparation of submissions to regulatory authorities and ethics committees.
• Assist with study start-up and site activation activities.
• Provide operational support to Clinical Project Managers and Clinical Research Associates (CRAs).
• Organize study meetings, prepare agendas, participate in discussions, and draft meeting minutes.
• Ensure clinical documentation is complete, accurate, and compliant with ICH-GCP requirements.
• Collaborate with cross-functional teams across international clinical studies.
• Provide back-up support for other clinical operations team members when required.

• Strong experience supporting international clinical trials.
• Experience with eTMF management, Investigator Site Files (ISF), and clinical study documentation.
• Good understanding of ICH-GCP guidelines (recent certification preferred).
• Experience supporting study start-up, feasibility, and regulatory activities.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Fluent English (written and spoken).

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.

Here’s what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.