International Clinical Trial Operations Specialist

Excelya; Saclay; On-site; EUR 34,000 - 52,000; Full time

Job summary

Excelya is seeking a Clinical Trial Assistant to support the operational management of international clinical studies. You will collaborate with Clinical Project Managers and CRAs across multiple countries, helping with study coordination, documentation management, regulatory support, and clinical operations activities.

You will manage eTMF and ISF, participate in feasibility and site selection, and assist with regulatory submissions while ensuring ICH-GCP compliance.

Qualifications

• Fluent English (written and spoken).
• Experience with international clinical trials and regulatory processes.
• Familiarity with eTMF and ISF management and clinical study documentation.
• Knowledge of ICH-GCP guidelines.

Responsibilities

• Manage Sponsor Trial Master Files (eTMF) and essential study documents 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.
• Assist with study start-up and site activation activities.
• Provide operational support to Clinical Project Managers and CRAs.
• Organize study meetings, draft agendas and minutes.
• Ensure clinical 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 when required.

Skills

English (Fluent)

eTMF management

ISF management

ICH-GCP guidelines

Study start-up/feasibility

MS Office

Tools

Microsoft Office

Job description

Excelya is seeking a Clinical Trial Assistant to support the operational management of international clinical studies. You will collaborate with Clinical Project Managers and CRAs across multiple countries, helping with study coordination, documentation management, regulatory support, and clinical operations activities.

You will manage eTMF and ISF, participate in feasibility and site selection, and assist with regulatory submissions while ensuring ICH-GCP compliance.