Emplois actuels liés à Coordonnateur Study Start-up - Paris, Île-de-France - AstraZeneca
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Coordonnateur Study Start-up
Il y a 4 mois
Vos responsabilités sont les suivantes:
- Constituer, soumettre, assurer le suivi des dossiers de demandes d'avis et d'autorisation d'essai clinique auprès de l'ANSM et des Comités de Protection des Personnes (CPP) dans le cadre des soumissions réglementaires (initiales et amendements) sous directive européenne 2001/20/CE et règlement européen 536/2014 (partie II)
- Constituer, soumettre et assurer le suivi des dossiers de demandes d'avis et d'autorisation d'études de performance auprès de l'ANSM et des Comités de Protection des Personnes (CPP) dans le cadre des soumissions réglementaires (initiales et amendements)
- Etre l'interlocuteur règlementaire auprès de l'ANSM, du CPP et des équipes réglementaires en R&D
- Participer aux réunions des équipes projet pour la coordination des activités réglementaires CPP et ANSM
- Constituer et soumettre la documentation règlementaire nécessaire pour supporter l'activité des ESR
- Assurer la documentation et coordination des activités relatives à l'approvisionnements en produits expérimentaux
- Assurer le contrôle qualité des documents qui sont soumis à l'ANSM et au CPP, notamment la revue et validation des ICFs (documents d'information et consentement des patients) et tout document destiné aux patients des essais
Toutes ces activités sont assurées en partenariat constant avec les équipes projet, afin de fournir un support de qualité, proactif et anticipé.
Votre profil:
- Expérience en recherche clinique
- Expérience en soumission de dossiers réglementaires
- Bon niveau d'anglais
- Capacité de gestion multi-projets
- Rigueur scientifique, organisation, négociation, qualités relationnelles, diplomatie, esprit d'analyse et de synthèse, qualités pédagogiques
Télétravail:
Ce poste nécessite une présence de 2 à 3 jours par semaine au Siège, comme le prévoit le règlement AstraZeneca.
Ce poste est ouvert aux personnes en situation de handicap.
