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Site Coordinator H/F - 95

Description du poste

  • Excelya

  • Boulogne-Billancourt - 95

  • CDI

  • Publié le 8 Août 2025

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

Join Excelya, whereAudacity, Care, and Energydefine who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth GO hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities
- Coordinate and oversee the full clinical site lifecycle (initiation, activation, monitoring, close-out) across all participating centers, under delegation of the Clinical Project Manager (CPM).
- Draft key study documents such as the Monitoring Plan, internal manuals, and center-facing guides (e.g., for randomization and treatment unit management).
- Supervise and support CRAs involved in the study : training, visit scheduling, on-site and remote monitoring supervision, review and approval of reports.
- Ensure regulatory and operational compliance throughout the study in line with protocol, SOPs, and ethical standards.
- Monitor study progress using tools like the Clinical Trial Management System (CTMS) and oversee maintenance of the Trial Master File (TMF).
- Lead communication with sites via the CRA team : share newsletters, study updates, recruitment status, and protocol changes.
- Contribute to study setup activities : database (eCRF) design, risk assessments, resource planning, and coordination with study centers.
- Support centralized medical monitoring and participate in review of protocol deviations and study risk mapping.
- Oversee close-out activities : TMF completion, final quality checks, visit planning, and archiving.
- Collaborate cross-functionally, report to hierarchy, and contribute to departmental meetings and collaborative initiatives.

Compétences requises

  • Pro-activité
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