DESCRIPTION :
* 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.
Code d'emploi : Coordinateur (h/f)
Domaine professionnel actuel : Gestion et Administration des Affaires (autre)
Niveau de formation : Bac+5
Temps partiel / Temps plein : Plein temps
Type de contrat : Contrat à durée indéterminée (CDI)
Compétences : Système de Gestion des Essais Cliniques, Bases de Données, Anglais, Français, Éthique, Sens de l'Organisation, Biologie, Travaux Cliniques, Audit de la Qualité, Maintenance et Dépannage, Soins Infirmiers, Monitoring à Distance, Gestion des Ressources, Analyse de Risques, Archivage et Classement, Randomisation (randomness)
Type d'annonceur : Employeur direct