Clinical Trial Assistant - Rare Diseases 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.AbouttheJob

JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.

Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovationandmakinganimpactintheclinicalresearchspace,whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth.

Main Responsibilities

- Support the clinical project management and monitoring of clinical studies, ensuring coordination with CROs, vendors, laboratories, and internal teams.
- Act as an active member of the study team, contributing to service provider oversight within company procedures and standards.
- Manage the Trial Master File (TMF): monitoring, QC review, and archiving to ensure quality, completeness, and audit readiness.
- Support financial tracking and documentation: update internal systems, manage invoices, purchase orders, and assist with study budget forecasts.
- Handle transparency reporting (e.g., EFPIA, US) and ensure proper documentation from service providers and study activities.
- Coordinate operational and administrative activities such as meeting preparation, contract signature collection, insurance renewals, shipment coordination, and collection of legal study documents.
- Maintain shared workspaces (e.g., OneDrive, SharePoint, Box) and ensure accurate data entry and status updates in CTMS.
- Perform all activities in full compliance with company SOPs and quality standards, ensuring accuracy, timeliness, and regulatory adherence.