Global Clinical Trials Coordinator

Excelya; Palaiseau; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

Excelya is seeking a Clinical Trial Assistant to support the operational management of international clinical studies, collaborating with Clinical Project Managers and CRA teams across multiple countries.

You will help with study coordination, documentation management, regulatory support, and broader clinical operations activities, ensuring ICH-GCP compliance and cross-functional teamwork.

Formación

• Experience supporting international clinical trials.
• Experience with eTMF management, ISF, and clinical study documentation.
• Solid knowledge of ICH-GCP guidelines (certification preferred).
• Experience supporting study start-up, feasibility, and regulatory activities.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Fluent English, both written and spoken.

Responsabilidades

• 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.

Conocimientos

International trials

eTMF

ISF

ICH-GCP

Regulatory support

Study start-up

MS Office

English

Herramientas

MS Office Suite

Descripción del empleo

Excelya is seeking a Clinical Trial Assistant to support the operational management of international clinical studies, collaborating with Clinical Project Managers and CRA teams across multiple countries.

You will help with study coordination, documentation management, regulatory support, and broader clinical operations activities, ensuring ICH-GCP compliance and cross-functional teamwork.