Project Manager - Clinical Trial

Banook

Banook , est un prestataire spécialisé en services cliniques , partenaire des sponsors et des CRO, apportant une expertise reconnue en Cardiac Safety, Central Imaging, Endpoint Adjudication, Functional Respiratory Imaging et eCOA.

Nous recherchons un(e) Chef de projet en essais cliniques pour piloter des programmes complexes de bout en bout, en garantissant une exécution conforme aux BPC (GCP), aux guidelines ICH, aux SOP, aux délais et aux objectifs financiers , tout en assurant l’excellence opérationnelle et l’alignement des parties prenantes.

Rejoindre Banook, c’est contribuer à des essais cliniques à fort impact dans un environnement international, exigeant et orienté qualité.

Responsabilités principales

Piloter des projets d’essais cliniques de bout en bout (mise en place, conduite, clôture)
Être l’ interlocuteur principal des sponsors et garantir leur satisfaction
Coordonner des équipes transverses (Data Management, QA, Logistique, Réglementaire, Finance)
Assurer la conformité aux BPC (GCP), aux guidelines ICH et aux SOP internes
Élaborer et maintenir les plans de management de projet (PMP), analyses de risques et documentation étude
Suivre les KPI, délais, livrables et performance des projets
Piloter la gestion des risques, des écarts et des CAPA
Suivre les budgets, prévisions et aspects financiers des projets
Contribuer aux audits, inspections et activités qualité

Profil recherché

Diplôme en sciences de la vie, recherche clinique ou domaine connexe
Minimum 3 ans d’expérience en gestion de projets cliniques (CRO, pharma, biotech ou prestataire spécialisé)
Bonne maîtrise du cycle de vie des essais cliniques, des BPC/GCP, des guidelines ICH et de la réglementation
Expérience en projets multicentriques ou internationaux appréciée
Certification PMP, PRINCE2 ou équivalent (un atout)
Positionnement différenciant en tant que prestataire spécialisé
Projets cliniques internationaux et complexes
Culture forte de qualité, d’éthique et d’excellence opérationnelle

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Vacancy posted 17 hours ago

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