Clinical Trial Assistant

Excelya; Saclay; Hybrid; EUR 36,000 - 52,000; Full time

Job summary

Excelya is seeking a Clinical Trial Assistant to support the operational management of international clinical studies. You will work closely with Clinical Project Managers and CRA teams across multiple countries to coordinate studies, manage essential documentation, and provide regulatory support.

The role emphasizes study coordination, regulatory compliance, and proactive collaboration with cross-functional teams in a fast-paced CRO environment. English proficiency is required.

Qualifications

• Strong experience supporting international clinical trials.
• Experience with eTMF management and ISF documentation.
• Solid understanding of ICH-GCP guidelines.
• Experience supporting start-up, feasibility and regulatory activities.
• Proficient in MS Office applications.

Responsibilities

• Manage Sponsor Trial Master Files (eTMF) and study documentation with Clinical Project Managers.
• Support Investigator Site File (ISF) preparation, maintenance and tracking.
• Contribute to feasibility activities and site selection processes.
• Assist 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 and draft minutes.
• Ensure documentation is complete, accurate, and compliant with ICH-GCP.
• Collaborate with cross-functional teams across international studies.
• Provide back-up support for other clinical operations team members.

Skills

International trials experience

eTMF management

ISF management

ICH-GCP knowledge

Study start-up & regulatory support

MS Office (Word/Excel/PowerPoint)

English proficiency

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.

Qualifications

• 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.