Contract specialist
il y a 2 semaines
Le Spécialiste Contrat est responsable de la coordination, de la préparation et de l'exécution des contrats d'études cliniques en étroite collaboration avec les Startup manager (chefs de projets locaux), les gestionnaires de projets cliniques, les ARC startup et les spécialistes finances conformément aux processus et aux exigences réglementaires.
Responsabilités:
• Soutenir la stratégie de démarrage des essais cliniques du pays en étroite collaboration avec les équipes Démarrage pour s'assurer que les délais et les livrables sont respectés conformément aux engagements du pays
• Être responsable de la coordination, de la préparation et de l'exécution des contrats d'études cliniques et des avenants pour les projets assignés
• Élaborer les grilles budgétaires et négocier les conditions financières et juridiques, faire remonter les problèmes le cas échéant
. Anticiper les types de contrats avec chaque intervenant et les soumissions aux instances ordinales le cas échéant
• Suivre et superviser l'état d’avancement des contrats incl. envoi et retour des contrats, être garant du rétroplanning afin que les mises en place dans les centres investigateurs soient réalisées conformément au planning.
• Être le point de contact unique pour les services juridiques et Ethic Risk & Compliance locaux (par exemple, pour les sujets de remboursement des patients)
• Développer et normaliser les modèles de contrats locaux et les MSA, coordonner et renouveler les divers contrats cadres avec les partenaires.
• Assurer le respect des normes financières, de la législation en vigueur, des exigences ICH/GCP, IRB/IEC, Autorité de santé et SOP
• Mettre en œuvre des processus innovants et efficaces alignés avec la stratégie, être force de proposition sur l’amélioration des outils, participer à des groupes de travail nationaux et/ou internationaux.
. Faire le lien avec les équipes dédiées à la facturation afin de faciliter les discussions avec les centres investigateurs.
Notre client recherche une personne ayant minimum 2 ans d'expérience en contrat au sein d'un laboratoire ou d'une CRO.
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Contract specialist
il y a 2 semaines
Rueil-Malmaison, France Ividata Life Sciences Temps pleinLe Spécialiste Contrat est responsable de la coordination, de la préparation et de l'exécution des contrats d'études cliniques en étroite collaboration avec les Startup manager (chefs de projets locaux), les gestionnaires de projets cliniques, les ARC startup et les spécialistes finances conformément aux processus et aux exigences réglementaires. ...
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Contract specialist
il y a 2 semaines
Rueil-Malmaison, Hauts-de-Seine, France Ividata Life Sciences Temps pleinLe Spécialiste Contrat est responsable de la coordination, de la préparation et de l'exécution des contrats d'études cliniques en étroite collaboration avec les Startup manager (chefs de projets locaux), les gestionnaires de projets cliniques, les ARC startup et les spécialistes finances conformément aux processus et aux exigences réglementaires. ...
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Contract specialist
il y a 2 semaines
Rueil-Malmaison, Hauts-de-Seine, France Ividata Life Sciences Temps pleinLe Spécialiste Contrat est responsable de la coordination, de la préparation et de l'exécution des contrats d'études cliniques en étroite collaboration avec les Startup manager (chefs de projets locaux), les gestionnaires de projets cliniques, les ARC startup et les spécialistes finances conformément aux processus et aux exigences réglementaires. ...
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