Clinical Trial Assistant H/F
2 weeks ago
Aixial Group, CRO (Clinical Research Organization), spécialisée en Life Sciences. Nous apportons un support technique aux laboratoires en phase d’études cliniques, pré et post market.
Depuis 2014 nous faisons partie de la famille Alten. Nous nous développons en France , Belgique , Suisse , République Tchèque , Danemark , UK , US … avec toujours des perspectives de s’élargir à l’international.
Aixial Group , intervient sur des modèles d’outsourcing et insourcing pour les activités d’opération clinique, affaires réglementaires, assurance qualité, vigilance, biométrie, HEOR… pour des comptes pharmaceutiques , cosmétiques , des dispositifs médicaux , biotechnologie , nutrition …
Aixial Group continue de s’agrandir et de recruter dans le domaine des études cliniques.
Pour en savoir plus:
Nous sommes à la recherche d’un Clinical Trial Assistant H/F dont les missions seront les suivantes (liste non-exhaustive) :
- Assurer la gestion administrative et réglementaire des études dans le respect des procédures
- Créer et assurer la gestion des documents du Trial Master File
- Gérer les courriers, mailings et comptes rendus des réunions associées aux études
- Participer à la mise en place des contrats et conventions en collaboration avec le chef de projet et le département juridique
- Assurer le suivi financier des factures des études
- Assurer la mise en place et la mise à jour des tableaux de suivi et des bases de données
- Organiser et participer aux réunions (internes ou externes) de suivi de l’étude
- Assurer le support logistique des études (documents et matériels nécessaires à la mise en place des protocoles dans les centres)
- Gérer l’archivage des études
- Participer au process qualité dans son domaine d’activité
Votre profil :
- Titulaire d’un BAC+2, BAC+3 (scientifique, biomédical, ou équivalent), vous justifiez de 2 ans d’expérience sur un poste similaire
- Vous maîtrisez la facturation/grille de surcoût ainsi que la collection et le suivi des contrats des études cliniques
- Vous maîtrisez la gestion du Trial Master File
- Vous faites preuve d’organisation, d’autonomie et de fiabilité
- Vous pratiquez un anglais professionnel à l’écrit comme à l’oral
- Poste à pourvoir en Auvergne-Rhône-Alpes
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