Clinical Monitoring Lead
il y a 2 semaines
Notre client recherche actuellement pour un laboratoire pharmaceutique un Clinical monitoring lead.
Vos missions:
- Assurer un démarrage d'étude efficace et approfondi en supervisant l'équipe clinique des CRO et en travaillant en étroite collaboration avec les autres membres de l'équipe
- S'assurer que le rapport de faisabilité est exhaustif, examiner la faisabilité du site rapports, soutenir le GCPM dans la sélection du site, vérifier la collecte en temps voulu des documents d'étude essentiels
- Soutenir le CRO clinique dans la formation des ARC sur toutes les activités opérationnelles spécifiques à l'étude
- Préparer et / ou aider à la production de tous les documents nécessaires pour superviser la mise en œuvre, le suivi et les rapports de l'activité clinique
- Personnaliser le modèle d'indicateur clé de risque/performance du site
- Valider les documents finaux de l'étude clinique
- Co-surveiller les études cliniques en assurant un contact adéquat avec les sites investigateurs, en identifiant et en résolvant les problèmes de progression de l'étude, en vérifiant les données en interne ou en effectuant des visites de co-surveillance
- Participer aux revues de données d'études cliniques
- Effectuer diverses fonctions liées à l'étude pour assurer l'exécution des études cliniques et agir en tant que back-up du CRM sur demande
Vous disposez d’un diplôme Bac +5 dans un domaine scientifique. Vous justifiez d’une expérience d’au moins 3 ans dans la coordination d’études clinique au sein de l’industrie pharmaceutique.
Vous assumez la responsabilité de coordonner les activités de surveillance clinique, de superviser les activités de gestion clinique / de site du CRO et de co-surveiller les études cliniques internationales assignées conformément aux exigences réglementaires, aux directives de bonnes pratiques cliniques (BPC) et aux SOP, afin de contribuer à la réalisation des objectifs de développement clinique et d'atteindre l'excellence clinique. Vous parlez anglais couramment.
Hays est le leader mondial du recrutement spécialisé. Nos solutions d’embauche permettent de vous faire bénéficier d’avantages exclusifs (Prime de participation, plan d’épargne, CSE actif ). N’attendez plus pour rejoindre notre structure et bénéficier de notre réseau et de notre spécialisation. #1346775
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