Global Clinical Trials Coordinator (eTMF/ISF)

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

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.