Data Manager

il y a 1 mois


Dijon, Bourgogne-Franche-Comté, France Harry Hope Temps plein

Rattaché au Responsable Data Management vous assurez la gestion des données des projets confiés à l'entreprise pour le compte de Promoteurs, en étroite collaboration avec des membres des équipes projets, dans le respect de la réglementation en vigueur (BPC, BPE, SOPs métiers etc...), afin de garantir la qualité des données collectées et à analyser.
A ce titre, vous suivez tout au long de sa durée, le projet de recherche qui vous est confié.
De plus, vous représentez le contact privilégié du Promoteur et de l'équipe projet pour les activités data management de l'étude.
De même, en tenant compte des spécificités de l'étude et des exigences du Promoteur, vous appliquez les procédures opératoires se rapportant aux activités de data management du projet.
En outre, vous êtes responsable de la validation des développements et collaborez à la validation des développements conjointement avec le Département Informatique. A savoir, vous participez à l'élaboration du guide de saisie en collaboration avec IT (eCRF) et chef de projet, et assurez le suivi de la validation des eCRFs avant mise en production.
Qui plus est, vous assurez le contrôle qualité de la base de données cliniques et le rapport de ce contrôle qualité pour les saisies de CRFS/Questionnaires papiers et contrôlez l'exhaustivité des signatures des eCRFs avant import, ainsi que l'exhaustivité des données importées (nb de patients, nb d'AES, SAES, ...).
Vous participez également, à la mise en oeuvre et au déroulement de la validation du Système Informatisé pour un projet donné (ex : cahier des charges, analyse de risque, protocole de validation, jeux de test à réaliser, rapport de validation etc.) conformément aux procédures applicables.
Enfin, vous assurez la validation et la documentation des modifications et participez à la formation des utilisateurs.


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