Global Clinical Trials Operations Specialist

Excelya; Saclay; Híbrido; EUR 36.000 - 52.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

International trials experience

eTMF management

ISF management

ICH-GCP knowledge

Study start-up & regulatory support

MS Office (Word/Excel/PowerPoint)

English proficiency

Herramientas

Microsoft Office

Descripción del empleo

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.