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Clinical Data Manager

Il y a 3 mois


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Cette entreprise a pour but de soutenir la réalisation d'essais cliniques de qualité supérieure, visant à obtenir les approbations réglementaires nécessaires pour commercialiser des solutions bénéfiques pour les patients à l'échelle mondiale. Ils se concentrent sur l'innovation et la fiabilité, pour améliorer les processus de prise de décision et réduire les coûts tout en respectant les normes de bonnes pratiques cliniques et les réglementations internationales.

Missions

  • Au sein de la Direction des Affaires Médicales, vous apportez une expertise solide dans la gestion des données des études cliniques en assurant la production de données cliniques cohérentes et de qualité dans le respect des délais et des budgets conformément aux plans de développement.
  • Vous réalisez et encadrez les activités de data management nécessaires à la mise en place et au suivi des essais cliniques jusqu'à leur clôture.
  • Vous représentez le data management au sein d'équipes multidisciplinaires et apportez votre expertise en la mettant au service des projets et vous interagissez avec les partenaires.
  • Vous participez à la définition des paramètres, cahiers des charges, budgets et au suivi attentif des prestations avec les sous-traitants.
  • Vous êtes en charge de la revue, de la validation et du suivi des délivrables, des paramètres techniques et la documentation fournie par les prestataires.
  • Vous contribuez à l'évolution des standards en établissant des procédures et méthodes de travail en collaboration directe avec vos collègues de l'Assurance Qualité.

Profil

  • Titulaire d'un Bac +5 dans le domaine scientifique, vous justifiez d'au moins 2 ans d'expérience dans la gestion d'études cliniques.
  • Vous maîtrisez Ennov Clinical ou un système similaire et possédez des connaissances des standards CDISC/SDTM.
  • Vous disposez d'un bon relationnel et démontrez de l'autonomie et de la flexibilité.
  • Vous êtes dynamique et motivé.

À propos de NoSstop : Nous sommes NonStop, un acteur majeur du recrutement en Europe et désormais aux États-Unis. Nous sommes passionnés par l'alignement des talents avec les opportunités et œuvrons sans relâche pour aider nos clients à recruter les meilleures compétences pour leurs équipes. N'hésitez pas à consulter notre site web pour davantage d'informations.