Bordet - Clinical Data Manager Clinical Trials
il y a 2 jours
**Société**:
L’Hôpital Universitaire de Bruxelles (H.U.B) regroupe l’Hôpital Erasme, l’Institut Jules Bordet et l’Hôpital Universitaire des Enfants Reine Fabiola (HUDERF). Créé en 2021 à l’initiative de la Ville de Bruxelles et de l’Université Libre de Bruxelles (ULB), ce grand pôle hospitalier universitaire garantit à la fois des soins de santé de haute qualité et accessibles à tous ainsi que l’excellence dans la formation et la recherche. L’H.U.B compte 1.420 lits d’hospitalisation et plus de 6.000 membres du personnel, dont 841 ETP médecins et 3.975 ETP non médicaux. L’H.U.B a pour ambition d’offrir à l’ensemble de ses équipes un cadre de travail épanouissant et attractif, avec des possibilités de formation et d’évolution professionnelle, tout en garantissant la pérennité et donc la viabilité financière de l’ensemble.
**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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