Juriste Clinical Trial Center
il y a 2 semaines
Le « Clinical Trial Center » (CTC) a pour mission de professionnaliser la recherche clinique dans l’institution et de couvrir tous les aspects relatifs à la recherche commerciale et à la recherche académique tant sur le plan économique qu’organisationnel.
En tant que juriste CTC pour les contrats recherche clinique, vous êtes responsable de la prise en charge de l’aspect légal des contrats pour la recherche clinique organisée aux Cliniques universitaires Saint-Luc.
Vous mettez à profit vos connaissances réglementaires au bénéfice du CTC selon deux axes principaux:
Axe contrats : gestion des contrats de recherche clinique
- Vous analysez du point de vue réglementaire les propositions de contrats de recherche commerciaux et académiques, MTA, DPA et autres conventions avec les partenaires extérieurs.
- Vous assurez la négociation réglementaire de ces contrats avec le partenaire extérieur jusqu’à finalisation.
- Vous êtes l’intermédiaire entre le service juridique ou le DPO et le partenaire académique/commercial pour les aspects juridiques liés aux contrats de recherche nécessitant leur support.
- Vous fonctionnez en partenariat avec le référent CoFi (Contrats, Finances et Reporting) gérant l’aspect financier du contrat.
- Vous assurez le reporting de la gestion des contrats dans le logiciel interne de recherche clinique
Axe général « CoFi » et reporting
- Vous participez au maintien des tableaux de bord et au rapport d’activités propres à la cellule CoFi du CTC;
- Vous participez aux audits d’organismes officiels et au processus d’accréditation recherche clinique ainsi qu’à son maintien;
- Vous respectez et vérifiez la bonne conformité de votre activité et celle des différents intervenants aux procédures internes et externes (légales) en matière de recherche clinique;
- Vous participez activement aux réunions de service du CTC et de la cellule CoFi;
**Profil**:
Savoir et savoir-faire:
- Diplôme de master en droit. Diplôme universitaire/équivalent ou expérience assimilée (ou bachelier expérimenté) orientation juridique
- Connaissance des législations belges et européennes en lien avec la recherche clinique et le GDPR.
- Maîtrise des Bonnes Pratiques Cliniques ("Good Clinical Practice"), normes de qualité éthique et scientifique conformément aux principes de la déclaration d'Helsinki
- Une expérience dans le domaine de la recherche clinique, de l'administration des études cliniques est un atout.
Autres connaissances requises:
- Connaissance parfaite du français
- Connaissance de l'anglais écrit et oral
- Connaissance des logiciels informatiques type « bureautiques » : (Word, Excel, PowerPoint,... )
Savoir-être:
- Motivation pour les aspects juridiques et organisationnels liés à la recherche
- Capacité à opérationnaliser les aspects juridiques liés à la recherche clinique pour des non-juristes
- Organisation rigoureuse, capacité d'analyse et de synthèse
- Sens de la confidentialité et des responsabilités
- Capacité d'accueil et de travail en équipe, esprit d'initiative
**Spécificité du poste**:
- Barème IFIC 16
- Assurance Groupe
**Avantages**:
Nous vous offrons:
- Un package salarial attractif : reprise de votre ancienneté valorisée dans la fonction,
- Une fonction variée et passionnante dans un environnement de travail à la pointe de la technologie
- 28 jours de congé annuels
- Une ambiance conviviale, multidisciplinaire et riche de sens
- Un accès à de nombreuses 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) avec des commerces et services de proximité (alimentation, pharmacie, école, crèche, plaines de vacances)
- Avantages octroyés par de nombreux commerces et fournisseurs, sport à prix réduit
- Nombreuses activités et initiatives pour soutenir et motiver nos collaborateurs
**Niveau d'études requis**:
Master
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