Clinical Trial Assistant F/H
il y a 4 semaines
Créée en 2014, Excelya est une organisation de recherche sous contrat (CRO) « people centered ».
Nous proposons une expérience personnelle et authentique au sein d'une jeune entreprise de santé ambitieuse en passe de devenir le leader de la recherche clinique en Europe grâce à nos 800 Excelyates. Notre modèle unique de service de fournisseur à guichet unique - tirant parti d'un service complet et fonctionnel de fournisseur de services et de conseils - permet à nos Excelyates d'évoluer à travers un large éventail de projets. En collaboration avec des experts de premier plan, Excelya fait progresser les connaissances scientifiques, managériales et humaines pour améliorer le parcours du patient.
Pour les membres de notre équipe, exceller avec soin, c'est bénéficier d'un environnement professionnel stimulant qui encourage la participation personnelle, intellectuelle et opérationnelle afin qu'ensemble nous puissions être les meilleurs dans notre domaine. Nous nous engageons à donner à chaque Excelyate les moyens d'exprimer ses talents naturels, de développer son plein potentiel et de s'investir dans notre projet unique.
Pour en savoir plus sur nous, visitez www.excelya.com
Au sein de l'Opérations Cliniques France, Afrique et Moyen-Orient d'un laboratoire international, le consultant travaillera en étroite collaboration avec divers Chefs de Projet et équipes de Chefs de Projet Clinique (CRA). La personne sera en charge de plusieurs études cliniques et de tâches transversales.
- Gestion du dossier promoteur, eTMF et documents papiers originaux, en collaboration avec les Chefs de Projet,
- Gestion de la préparation et du suivi de l'Investigator Study File, en collaboration avec les Chefs de Projet et les CRA,
- Contribution au processus de faisabilité des études en collaboration avec les Chefs de Projet,
- Contribution à la préparation des dossiers de soumission aux autorités compétentes et à la mise en œuvre des études dans les centres,
- Support opérationnel aux Chefs de Projet,
- Préparation, organisation, participation et rédaction des comptes rendus des réunions d'équipe/étude,
- Assurer le back-up des autres assistants lorsque nécessaire.
Profil requis :
- Connaissance du monde de l'industrie pharmaceutique,
- Expérience d'au moins 3 ans dans la gestion d'essais cliniques internationaux,
- Bonne connaissance des BPC (formation ICH-GCP datant de moins de 2 ans),
- Bonnes compétences informatiques sur Microsoft Word, Excel et PowerPoint,
- Anglais courant.
Les qualités personnelles requises :
autonomie, organisation, rigueur, goût pour le travail en équipe, aisance relationnelle, polyvalence, réactivité, esprit d'équipe.
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