Clinical Trial Assistant H/F - 75

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

As a Clinical Trial Assistant at Excelya, you will be at the forefront of clinical research, playing a crucial role in supporting the management of clinical trials. Our core values of Audacity, Care, and Energy drive us to push boundaries and create innovative solutions in the clinical landscape. This position thrives on teamwork and initiative, where every contribution counts to achieve our projects' success.

Main Responsibilities

- Support Clinical Project Managers and Clinical Research Associates (CRAs) in the administration and organization of clinical trials.
- Maintain the Trial Master File (TMF) and ensure all documents are compliant with ICH-GCP guidelines.
- Assist with the preparation and organization of study documentation, including regulatory submissions and site files.
- Coordinate study supplies and materials, ensuring timely distribution to sites.
- Utilize clinical trial management systems (CTMS) and electronic TMF systems to track trial progress and documentation.
- Schedule and facilitate meetings, prepare agendas, and track action items.
- Act as a liaison with clinical trial sites to manage queries and document submissions.
- Assist in site activation and closure, including regulatory document management.
- Manage administrative duties related to study contracts and vendor relationships.
- Ensure all clinical documentation is audit-ready and assist in inspection preparations.