Clinical Monitoring Lead

il y a 20 heures

Paris, France HAYS Temps plein

Prêt pour une nouvelle aventure ?

Hays Life Sciences, leader mondial de la prestation de service pour l’industrie de la santé recherche actuellement un Clinical monitoring lead pour un poste en home-based.

Les missions principales du poste sont les suivantes:

- Assumer la responsabilité de la coordination des activités de surveillance clinique, de la supervision des activités de gestion clinique/site de la CRO et de la co-surveillance des études cliniques internationales Ph2/3 assignées conformément aux exigences réglementaires, aux directives des bonnes pratiques cliniques (BPC) et aux SOPs, selon les normes de qualité les plus rigoureuses, dans le respect des délais et du budget, afin de contribuer à la réalisation des objectifs de développement clinique et d'atteindre l'excellence clinique.
- Coordonner la réalisation des livrables des études cliniques assignées au sein d'une organisation matricielle sous la direction des chefs de projet clinique (CPM).
- Expérience d'au moins 1 an (idéalement 2 ans) en tant qu'ARC Lead (par exemple), en coordination d'activités cliniques / d'activités de gestion de sites pour la mise en place et le déroulement d'études internationales (plusieurs sites/pays).
- Expérience en tant qu'ARC moniteur sur le terrain pendant au moins 3 ans (CROs ou industrie pharmaceutique).
- Excellente connaissance des bonnes pratiques cliniques (BPC), des réglementations ICH.
- Expérience dans la préparation de la documentation des études cliniques pour la mise en place, la maintenance et la clôture des études.
- Expérience dans la gestion et le développement des relations avec les CRO.
- Expérience des études mondiales (plusieurs pays/sites).
- Une expérience préalable dans le domaine thérapeutique des études en cours (neurosciences, oncologie) est un plus. #1309500

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