eTMF Manager
il y a 1 semaine
Nous recherchons un(e)
Expert(e) en Gestion d'eTMF
pour garantir la conformité, l'intégrité et l'accès de notre Dossier Permanent d'Étude Électronique (
eTMF
). Votre rôle est essentiel pour le succès des audits et inspections réglementaires, en assurant que la documentation de nos études cliniques respecte les standards internationaux les plus stricts.
Vos missions :
Assurer la gestion, la mise en conformité et la maintenance continue de l'eTMF (VeevaVault) selon les standards réglementaires internationaux (ICH-GCP, EMA, FDA).
Soutenir les équipes cliniques dans l'organisation, le suivi et la qualité documentaire tout au long des études.
Mettre en place et suivre les KPIs qualité, en garantissant un eTMF complet, actuel et exact.
Participer aux audits internes/externes et inspections réglementaires.
Former et accompagner les équipes sur les bonnes pratiques eTMF.
Profil recherché :
-Formation supérieure scientifique (Bac+5 ou équivalent).
Expérience confirmée en gestion d'eTMF ou en documentation d'études cliniques.
Connaissance solide des exigences réglementaires en recherche clinique.
Maîtrise de systèmes eTMF (Veeva)
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