Clinical Project Manager
Location
France
Posted
9 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Clinical Project Manager
TempoPHARMA
Role Description Rejoignez un acteur international de la santé grâce à TempoPHARMA ! Dans le cadre d'un CDD de 6 mois, vous intégrerez les équipes de notre partenaire avec une perspective d'internalisation à l'issue de la mission. Une excellente opportunité de démarrer sur un projet stratégique avant de rejoindre durablement un environnement stimulant et international. Nous recherchons un(e) Chef de projet Clinique pour accompagner le développement de médicaments, dispositifs médicaux et autres produits de santé dans un environnement international. - Piloter des études cliniques de A à Z - Coordonner les CRO, investigateurs et partenaires externes - Garantir le respect des délais, de la qualité et du budget - Superviser les documents d'étude (protocoles, CRF, rapports...) - Organiser les réunions de lancement et le suivi des projets - Assurer la conformité réglementaire (ICH-GCP) - Première mission : participer à la mise en place d'une étude de bioéquivalence sur un produit stratégique et contribuer à la rédaction des SOPs dédiées. - Par la suite, vous prendrez en charge un portefeuille varié d'études cliniques. Qualifications - Formation supérieure scientifique (Pharmacien, Sciences de la vie, Biologie, etc.) - Minimum 5 ans d'expérience en gestion d'études cliniques en laboratoire pharmaceutique, Biotech ou CRO - Connaissances des médicaments, dispositifs médicaux et/ou cosmétiques - Expérience en études de bioéquivalence - Bonne maîtrise des réglementations cliniques et des standards ICH-GCP - Expérience en oversight d'études cliniques et coordination multi-intervenants - Capacité à évoluer dans un environnement exigeant et à gérer des interlocuteurs complexes - Excellent sens de l'organisation, autonomie et assertivité - Anglais professionnel courant indispensable Benefits - Centre de formation interne - Carte Tickets Restaurant - Mutuelle d'entreprise familiale - Primes vacances - Chèques cadeaux Noël - Intégration et suivi personnalisé du consultant
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