Clinical Trial Assistant

Il y a 2 mois

BoulogneBillancourt, Hauts-de-Seine, France EXCELYA Temps plein

I. Excelya


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


II. Missions


Logistique d’étude Clinique:

  • Crée les documents administratifs de l’étude
  • Constitue le dossier de soumission à l’ANSM et au CPP
  • Crée et met à jour les tableaux de suivi de l’étude
  • Passe les commandes de matériel nécessaire à l’étude
  • Réunit et expédie le matériel nécessaire aux investigateurs
  • Saisit les données dont elle est responsable dans les outils dédiés de suivi des Essais Cliniques (CTMS)


Gestion documentaire:

  • Constitue le « study master file » en coordination avec le chef de projet développement
  • Constitue le template ISF Investigateur et pharmacie en adaptant l’index aux spécificités de l’étude
  • Collabore étroitement avec les ARCS de l’étude afin d’assurer une gestion documentaire de qualité

Gestion budgétaire :

  • Assure l’établissement et le suivi des contrats et des conventions uniques,
  • Saisit les bons de commande dans IBUY
  • S’assure du règlement des factures, des honoraires des professionnels de santé et des surcoûts hospitaliers avec le RPD
  • Demande la création des HCP/HCO


Support Recherche Clinique :

  • Formation à CTMS pour les nouveaux arrivants (ARC, GEC et RPD) en collaboration avec les ARC et RPD en poste.
  • Formation et encadrement des nouveaux GEC


III. Profil


Vous justifiez d’au moins 3 ans d’expérience dans le secrétariat des essais cliniques d’un laboratoire pharmaceutique. Vous disposez d’une bonne maîtrise du pack Office (Word, Excel, PowerPoint). Vous avez également une expérience en eTMF VeevaVault ou autre système similaire. Vous parlez anglais couramment.

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