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International Clinical Operations Lead H/F
il y a 2 heures
Dans le cadre du pilotage d'études cliniques internationales de phases 1 à 3, IVIDATA Life Sciences recherche un(e) ICOL (International Clinical Operations Lead) expérimenté(e) pour coordonner les opérations cliniques sur le terrain et accompagner les équipes locales dans le respect des délais, du budget et des standards qualité. Vos responsabilités Coordination et supervision des activités cliniques locales dans plusieurs pays ; Liaison entre les équipes locales et internationales, consolidation et diffusion des informations pertinentes ; Suivi du budget des études cliniques et formation des équipes locales aux hypothèses budgétaires ; Participation active aux comités d'études (Study Teams), aux réunions d'investigateurs, aux revues de données ; Création et actualisation de la documentation clé : Monitoring Plan, Training Materials, Vendor Work Orders, etc. ; Encadrement des CROs et fournisseurs centraux impliqués dans les études (laboratoires, services patients…) ; Revue et mise à jour du Trial Master File ; Contribution aux stratégies d'inclusion patient ; Suivi des courbes de recrutement et mise en place d'actions correctives en cas de dérive ; Support aux audits et inspections : suivi des CAPA, gestion des écarts, amélioration continue. Votre profil Diplômé d'études supérieures (Master, Ingénieur, Pharmacie) dans une matière scientifique/technique pertinente telle que la chimie, la biologie ou équivalent. Au moins 5 ans d'expérience dans des fonctions similaires Connaissance approfondie des BPC/ICH-GCP et des SOP ; Expérience en gestion de prestataires (CROs, vendors…) ; Anglais courant (oral et écrit) indispensable ; Leadership, rigueur, sens de l'organisation et excellent relationnel ; Capacité à travailler dans un environnement international en constante évolution. Déplacements ponctuels à prévoir en France ou en Europe (1 à 2 fois / 6 mois). Pourquoi nous rejoindre ? Chez IVIDATA Life Sciences, nous plaçons l’expertise au cœur de nos actions.Aux côtés des grands acteurs du secteur (laboratoires pharmaceutiques, biotech, dispositifs médicaux, santé animale, cosmétique, nutrition…), nos consultants interviennent sur l’ensemble du cycle de vie des produits : de la recherche préclinique à l’industrialisation. Nos 160 consultants déploient leurs compétences dans cinq domaines clés :Biométrie, Opérations cliniques, Affaires réglementaires, Pharmacovigilance, Assurance Qualité. En rejoignant notre équipe, vous évoluerez dans un environnement stimulant, collaboratif et en constante évolution, où vos idées et votre expertise auront un impact réel. #J-18808-Ljbffr
