Clinical Project Manager
vor 2 Monaten
Nous recherchons un chef de projet clinique, pour l'un de nos clients prestigieux, de renommée mondiale et en pleine croissance, spécialisé dans les dispositifs médicaux, situé à Genève.
Faites partie du jeune et dynamique département de recherche clinique pour la mise en ?uvre d'études cliniques afin d'assurer la conformité aux réglementations (MDR, FDA...).
**Responsabilités**:
Vous serez responsable de la planification et de la gestion des études cliniques dans le respect des délais, des budgets et des normes de qualité.
**Vos principales responsabilités seront**:
- Mise en ?uvre, exécution et achèvement des projets de recherche clinique de l'entreprise.
- Responsable de la conformité aux réglementations locales, aux réglementations BPC et aux SOPs de la CRO dans les projets cliniques.
- Sélection et validation des investigateurs/sites et des fournisseurs (par exemple les CROs).
- Contribuer à la négociation et à la préparation des contrats et des budgets avec les tiers et les sites d'étude.
- Assurer une documentation de haute qualité tout au long de l'étude clinique.
- Gérer la documentation clinique essentielle pour les soumissions aux comités réglementaires et éthiques aux Etats-Unis.
- Gérer les CROs et s'assurer qu'ils respectent leurs engagements en termes de temps et de budget.
- Gestion des budgets des études cliniques, y compris les accords/budget des sites.
- Supervision des performances des organismes de recherche et/ou des visites de co-surveillance des sites participant aux projets cliniques sponsorisés.
- Communiquer régulièrement avec les sites participant aux projets cliniques.
**Votre profil**:
Formation scientifique (par exemple, biochimie, microbiologie, pharmacie, sciences biologiques ou sciences pharmaceutiques connexes).
Au moins **2 ans d'expérience dans les opérations cliniques et la gestion de projets (couvrant toutes les étapes d'une étude clinique) notamment au US et/ou Chine**
Expérience des études sur les dispositifs médicaux et/ou pharmaceutique
**Anglais courant** requis / Le français est un atout.
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