Head Country
Il y a 6 mois
Ce rôle est responsable de l'exécution et de la supervision des activités locales opérationnelles des essais cliniques, conformément aux directives ICH/GCP et aux réglementations nationales, aux politiques et procédures de notre compagnie, ainsi qu'aux normes de qualité internes et externes. La personne est responsable de la conformité réglementaire et financière locale, ainsi que de la délégation des tâches, le cas échéant.
- La responsabilité principale de ce rôle est de gérer et de diriger la stratégie et l'exécution de toutes les activités réglementaires, financières et logistiques associées aux études cliniques internalisées.
- Le rôle sera chargé de gérer les responsables seniors des opérations cliniques (Sr. COM), les responsables des opérations cliniques (COM) et les coordinateurs des essais cliniques (CTC) dans les pays ou groupes de pays, en fonction des exigences spécifiques du pays.
- Les responsabilités principales du rôle comprennent:
- Gérer les subordonnés directs, y compris les plans de performance et les plans de développement. Superviser la gestion des performances et le développement de carrière du personnel et gérer efficacement les problèmes de performance.
- Travailler en étroite collaboration avec les responsables des opérations cliniques au niveau national, le responsable des CRA et les chefs de groupe thérapeutique pour évaluer la stratégie du programme et l'alignement des livrables et des objectifs du projet.
- Collaborer avec les collègues du siège social pour contribuer à la stratégie de l'entreprise, en mettant l'accent sur les normes de pratique pour l'établissement des budgets des sites, la conclusion des contrats des sites, les consentements éclairés et la gestion des comités d'éthique centralisés et des autorités de santé concernées. Créer, promouvoir et diriger une stratégie pour les activités de démarrage rapide.
- Établir des procédures et des processus nationaux pour toutes les activités pertinentes (gestion des contrats des sites et négociation et escalade des budgets, soumissions et approbations réglementaires ; procédures et processus de gestion de la logistique et des achats de médicaments et de matériel pour le démarrage de l'étude).
- Veiller à ce que tous les projets disposent des ressources adéquates et soient suivis pour garantir une efficacité et une réalisation optimales des objectifs, des jalons et des cibles, tout en maintenant des normes de qualité élevées.
- Établir une stratégie de partenariat et de suivi de tous les fournisseurs/prestataires de services qui soutiennent la mise en œuvre opérationnelle et la gestion des responsabilités des responsables seniors des opérations cliniques, des responsables des opérations cliniques et des coordinateurs des essais cliniques. (Inclut les fournisseurs de main-d'œuvre, les prestataires de comités d'éthique centralisés, etc.)
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R281406
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