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 êtes responsable du support scientifique dans le service de neurochirurgie ainsi que de la coordination et du suivi de l'étude clinique auprès de chaque patient et ce, en partenariat avec les autres professionnels.

Vos activités principales sont:

- D'apporter un support pour les revues de la littérature, la réalisation de statistiques de base et la rédaction d’articles scientifiques ;
- De maintenir et entretenir des bases de données sur les pathologies principales du service et leurs interventions ;
- De participer à l'information et à la formation des différents acteurs impliqués par la recherche.

En collaboration avec le médecin investigateur, vous:

- Informez le patient et son entourage des objectifs de l'étude ;
- Informez de la conformité du consentement éclairé ou de l'accord parental recueilli par le médecin ;
- Expliquez au patient son implication et ses droits dans le cadre de l'étude ;
- Informez le patient des effets secondaires et indiquez au patient comment remplir les documents de suivi ad hoc ;
- Assurez le suivi du patient inclus dans l'étude clinique médicale ;
- Assurez un rôle d'éducation à la santé du patient et de sa famille ;
- Planifiez, coordonnez et vous assurez du respect des étapes du protocole de recherche ;
- Assurez le suivi du courrier émanant des acteurs de l'étude clinique médicale ;
- Collectez les documents requis pour l'étude, encodez les données dans les documents spécifiques de l'étude et assurez la vérification des données avec la firme ;
- Prenez en charge les visites de monitoring ;
- Participez aux visites d'inspection et d'audit ;
- Clôturez l'étude et assurez l'archivage ;
- Vérifiez les critères d'inclusion / exclusion des patients ;
- Assurez le suivi et la surveillance des effets secondaires, et contactez la firme pharmaceutique et le médecin investigateur ;
- Encadrez les étudiants ou les nouveaux collaborateurs à l'étude clinique.

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

- Vous disposez d'un diplôme de bachelier en soins infirmiers ou d'un Master en sciences biomédicales ou autre formation paramédicale
- Une formation en méthodologie de recherche et à l'analyse statistique constitue un atout
- Une expérience en milieu hospitalier est un atout
- Vous maitrisez les Bonnes Pratiques Clinique ("Good Clinical Practice"), les normes de qualité éthiques et scientifiques conformément aux principes de la déclaration d'Helsinki.
- Vous maitrisez les pathologies et traitements de la population de patients recensés pour la recherche clinique expérimentale.
- Vous disposez d'une vision pluridisciplinaire des différents services et intervenants.
- Vous disposez de bonnes connaissances du fonctionnement des équipes de soin et intégration.
- La connaissance parfaite du français est exigée.
- La connaissance de l'anglais médical écrit et oral et du néerlandais est un atout

Savoir-être:

- Vous poursuivez un objectif d'efficacité et de qualité dans l'accomplissement de votre travail et contribuez à fournir un meilleur service au patient.
- Vous avez un esprit analytique et des compétences organisationnelles
- Vous avez d'excellentes compétences relationnelles
- Vous respectez le secret professionnel
- Vous êtes orienté procédures
- Vous respectez les règles d'Hygiène Hospitalière.

**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 (alimentation, pharmacie)
- 20 jours de congés légaux additionnés de 4 jours de congés propres au secteur et de 4 jours de congés extra-légaux

**Niveau d'études requis**:
Master

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