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Erasme - Clinical Data Manager Clinical Trials
il y a 1 semaine
**Fonction**:
**Mission**:
Assurer et gérer les données récoltées au cours des études cliniques, en collaboration avec la Study Coordinatrice responsable.
**Tâches**:
- Vérifier que le traitement des données est réalisé en conformité avec les exigences réglementaires du CTCU, du GDPR et de l’étude concernée
- Garantir la confidentialité des données médicales gérées et transmises
- Garantir la qualité des données selon les bonnes pratiques cliniques (BPC) de data management
- Assurer la traçabilité de toutes les interventions sur la base de données (documentation Source)
- Participer à la rédaction et/ou à la révision du cahier d’observation (ECRF)
- Gérer la saisie, l’encodage des données
- Mettre en place, avec l’équipe des Data Managers et des Study Coordinateurs, l’adaptation de l’encodage selon la liste des contrôles (de complétude et de cohérence) pour chaque étude
- Contrôler les données et gérer les Demandes de Correction sur ECRF (Queries)
- Participer et s’assurer de la préparation de la revue des données (Monitoring, Data Base Lock, Audits, )
- Maintenir la mise à jour des données et de leur documentation en conformité avec les évolutions du protocole et du ECRF (amendements)
- Assurer le classement et l’archivage des documents concernant les activités de Data Management: documents papier de l’étude et documents informatiques en collaboration avec la Study Coordinatrice
- Assurer la gestion des « Site Monitoring Visits » (agenda) et collaborer avec les CRAs sur site ou à distance (mails, téléphone)
- Participer aux différents meetings : Initiation, Monitoring, Audits, Investigator’s Meeting (parfois), séminaires de formation,
- S’acquitter de toute autre tâche qui lui est assignée
**Profil**:
- Savoir : Disposer des connaissances techniques requises pour la fonction
- Savoir-être : Rigueur, Autonomie, Esprit d’initiative et Réactivité
- Savoir-faire : Précision, Communication, Sens du relationnel, Esprit d’équipe
**Offre**:
- Un contrat en CDI à 38 heures/semaine
- L’opportunité d’exercer une fonction variée
- Une rémunération attractive, assortie d’avantages extra-légaux (chèques repas, jours de congés extra-légaux)
- L´hôpital est facilement accessible en métro
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