Data Manager

Il y a 2 mois

Brussels, Belgique Cliniques Universitaires Saint-Luc Temps plein

En tant que Data manager et Coordinateur de recherche clinique, vous collaborez avec les responsables du CTC, du département de Neuropsychiatrie et Pathologies spéciales et du service de Neurologie afin de promouvoir, encourager et faciliter une recherche clinique académique et commerciale de qualité
Les tâches génériques sont:

- Assurer l'organisation et la coordination d’études cliniques dans le respect des Good Clinical Practices
- Tenir à jour et transmettre régulièrement le listing des protocoles ainsi que le nombre d’inclusions pour chacun d’eux
- Organiser et mettre en place son back-up, en informer ses supérieurs hiérarchiques et fonctionnels
- Déclarer tout accident, incident ou omission survenu dans sa pratique
- Participer
- à l'information, à l'éducation du patient dans un souci de promotion de santé et selon les GCP
- à la formation des équipes soignantes concernées par l'étude clinique médicale
- aux meetings d’investigateurs en accord avec ses supérieurs hiérarchiques et fonctionnels.
- Actualiser
- ses connaissances professionnelles en pathologies spécifiques de la population de patients concernés par l'étude clinique, en traitements innovateurs et expérimentaux en participant à des congrès, formations spécifiques
- ses connaissances professionnelles en participant à des formations spécifiques internes ou externes à l’institution

Les tâches spécifiques sont:

- Vérifier la faisabilité de l'étude en collaboration avec l'investigateur
- Participer à l’estimation des coûts relatifs à l’étude clinique
- Planifier, coordonner et s'assurer du respect des étapes du protocole de recherche dans les délais requis
- Vérifier les critères d’inclusion /exclusion des patients
- Participer à l’obtention de son consentement éclairé et expliquer l’étude aux patients répondant aux critères d’enrôlement
- Informer le patient des effets secondaires éventuels et l’éduquer à remplir les documents de suivi ad hoc
- Veiller au bon déroulement de l’étude clinique auprès de chaque patient et ce en partenariat avec les autres professionnels impliqués dans le suivi
- Collaborer à la gestion des traitements de l’étude clinique avec entre autres : la pharmacie, les unités de soins
- Prendre en charge des actes techniques requis par l’étude
- Assurer le suivi et la surveillance des effets secondaires
- Assurer la gestion administrative
- Prendre en charge la facturation et le suivi des remboursements liés à l’étude clinique
- Veiller au respect des instructions de prise en charge « étude/non étude » définies par l’investigateur principal et vérifier son exactitude au sein des programmes informatiques
- Prendre en charge les visites de Monitoring, d’inspection et d’audit
- Assurer le suivi et la surveillance des effets secondaires
- Clôturer l’étude vis-à-vis des différents intervenants concernés, répondre aux « queries », assurer la gestion de l’archivage et de la facturation

**Profil**:
Savoir et savoir-faire:

- Baccalauréat - et si possible études en relation avec soins de santé ou milieu médical (soins infirmiers)
- La maîtrise des Bonnes Pratiques Clinique ("Good Clinical Practice"), normes de qualité éthique et scientifique conformément aux principes de la déclaration d'Helsinki est un atout
- La connaissance des Directives, Règlements et Standards régissant la recherche clinique est un atout
- Une expérience préalable en recherche clinique souhaitable
- La connaissance parfaite du français est exigée
- La connaissance de l'anglais médical écrit et oral est nécessaire

Savoir-être:

- Aptitudes relationnelles, notamment : esprit d’équipe, qualité d’écoute, de communication, d’empathie, de négociation
- Rigueur et méthodologie
- Sens de l'organisation du travail et des responsabilités
- Esprit d'initiative et de synthèse
- Capacité à l'autonomie et à l'organisation personnelle du travail
- Capacité à travailler en interdisciplinarité
- Déontologie et respect du secret professionnel
- Volonté de perfectionnement professionnel et curiosité intellectuelle
- Respecter et vivre les valeurs de Saint-Luc

**Spécificité du poste**:
CDI avec clause résolutoire au terme du financement

**Avantages**:
Nous vous offrons:
Un package salarial attractif : reprise de votre ancienneté valorisée dans la fonction, sursalaire supérieur au taux mínimal de la commission paritaire en cas de prestations irrégulières, prime de fin d’année
Une fonction variée et passionnante dans un environnement de travail à la pointe de la technologie
Une ambiance conviviale, multidisciplinaire et riche de sens
Un accès à de nombreuse formations pour le développement continu de vos compétences
Des opportunités de carrière dans le cadre de la mobilité interne
Un site arboré facilement accessible (transports en commun ou parking gratuit) et des commerces de proximité (al

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