Data Contract Manager
il y a 3 semaines
Spécialisée dans le domaine de la Recherche Clinique, la société IT&M STATS développe un pôle de compétences dans les différents métiers de la Recherche Clinique (Data Managers, Biostatisticien(ne)s, Analystes Programmeurs SAS…)
Nous recherchons pour l’un de nos clients du secteur biopharmaceutique un(e) Data Manager expérimenté(e) .
Assurer la qualité des données pour l’analyse statistique
Superviser les activités de data management réalisées par les CROs
Participer à la sélection des sous-traitants / Valider les contrats de sous-traitance et leurs budgets / S’assurer de leur mise en œuvre dans les délais fixés et avec la qualité requise
Superviser les activités de Data Management (DM) réalisées par les CROs (de la mise en place du CRF au gel de la base de données)
Valider les livrables des CROs (e.g. plan de Data Management, CRF/Structure de la base de données, plan de validation des données, spécifications de transfert de données externes, spécifications SDTM / base de données au format SDTM)
Rédiger les spécifications de transfert des données externes / réconcilier les données externes
Contrôler la qualité de la base de données avant le gel de la base
Présenter l’avancement des activités DM à l’équipe projet
Programmer les rapports/contrôles utilisés par l’équipe clinique pour assurer la qualité des données
Vous êtes diplômé en Informatique et/ou filière scientifique (Bac + 2 minimum)
Vous avez environ 5 années d'expérience en CRO ou laboratoire pharmaceutique
Vous avez de solides connaissances en Data Management et du domaine clinique
Vous avez un anglais professionnel
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