Clinical Data Manager
il y a 2 semaines
France 03.04.2023
**Clinical Data Manager H/F**:
**Tasks**:
**Aixial Group**, CRO (Clinical Research Organization), spécialisée dans le Life Science. Nous travaillons avec les laboratoires pour apporter un support technique sur des projets cliniques des phases I à IV et post market.
Depuis 2014, nous faisons partie de la famille Alten. Nous développons nos activités en France, en Belgique, République Tchèque, Danemark, UK, US...avec encore des perspectives de s'étendre plus à l'international. On continue de s'agrandir, en intégrant Larix et CMED dans nos activités.
Aixial Group, intervient en outsouring, en insourcing, pour des laboratoires pharmaceutiques, cosmétiques, du medical device, biotechnologie, nutrition,...sur des activités des opérations cliniques, des affaires réglementaires, qualité, biométrie, pharmacovigilance, HEOR...
Aixial Group, continue de grandir, et de recruter dans les métiers des essais cliniques. Venez nous rejoindre, et découvrez notre site pour suivre l'actualité de nos offres.
Nous recherchons, un(e) **Clinical Data Manager F/H**, dont les missions seront les suivantes:
- Il est membre de l’équipe projet et interlocuteur pour les points de data-management du projet.
- Il revoie les protocoles des essais cliniques et contribue à l’établissement des modalités de recueil de données.
- Il s’assure de la réalisation des étapes de data-management dans les temps définis pour le projet en analysant les rapports d’avancement et en analysant les difficultés rencontrées et en proposant des solutions.
- Il s’assure que le travail a un niveau de qualité satisfaisant en réalisant des contrôles de qualité réguliers sur des échantillons durant toute la durée du projet : contrôle de la structure de la base de données, des résultats des programmes de validation, des queries générées et des tables de données.
- Il communique à l’équipe projet l’état d’avancement et les points difficiles et est attentif aux difficultés du reste de l’équipe et peut proposer des solutions.
- Il participe à l’amélioration de la gestion des données en proposant des modifications ou des nouveautés.
- Il participe à la mise en place et au maintien de la gestion documentaire des éléments de data-management.
- Il participe à l’archivage des essais pour les données, les programmes et la documentation des essais.
**Requirements**:
**Expérience professionnelles, qualifications et connaissances souhaitées**:
- Expérience en data-management d’au moins 1 ans.
- Expérience d’utilisation opérationnelle d’un logiciel de Data-Management
- Expérience de développement et d’utilisation de eCRF
- Expérience de programmation SAS
**Compétences linguistiques**:
- Excellent niveau d’anglais.
Poste à pourvoir en CDI dans la région parisienne et lyonnaise
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