Clinical Data Manager

1 week ago

india EURHASI Full time
Job Description

EURHASI recrute pour son client un Clinical Data Manager (H/F)

Notre client est un éditeur acteur majeur du codage médical, de la recherche clinique et de la qualité des soins au bénéfice des patients.

Le client n’accepte pas les candidatures nécessitant des démarches administratives pour une autorisation de travail (permis de séjour, permis de travail, autorisations diverses ...)

 

Mission

Le/La Clinical Data Manager est chargé(e) de réaliser la conception de bases de données cliniques et d’en assurer la gestion en respectant la réglementation en vigueur applicable aux protocoles de recherche biomédicale.

Sa principale mission est de structurer les données de recherche dans une base et d’assurer leur qualité pour préparer leur exploitation lors des analyses statistiques.

Sous la responsabilité de Lorraine Houvet, Responsable des Projets de Recherche Clinique et du développement, vous serez responsable des activités suivantes : 

Développement informatique 

  • Conception et mise en place des systèmes de gestion des bases de données cliniques
  • Réalisation des programmes informatiques et production de listing de données individuelles et des tables
  • Conception et validation des interfaces d’acquisition des données (le cas échéant)
  • Gel et verrouillage de la base de données cliniques

 

Contrôle de la cohérence des données

  • Conception, mise en place et suivi des contrôles de cohérence pour assurer la qualité des données
  • Participation à la définition des normes et documents standards des projets cliniques
  • Collecte et contrôle des fichiers électroniques des projets cliniques et transmission aux services ad-hoc
  • Garantie de la conformité et de la qualité des données, mise en place de processus de surveillance

Veille de l’information

  • Veille technologique sur les méthodes et les outils
  • Veille réglementaire
  • Gestion des dictionnaires médicaux utilisés dans les bases de données cliniques
  • Mise en conformité aux standards CDISC (Clinical Data Interchange Standards Consortium)

Profil
  • Niveau Bac +5 en biologie de la santé (option ingénierie, informatique ou data management) ou en informatique (avec une formation complémentaire en sciences de la vie) ou expérience équivalente 
  • Expérience d’au moins 3 ans en tant que gestionnaire de données cliniques
  • Compétences requises : 
  • Appétence pour mySQL, Python, SAS
  • Avoir travaillé en équipe pluridisciplinaire et en mode projet
  • Anglais courant
  • Un plus si vous avez une expérience en CRO (clinical research organization)
  • Un plus si vous avez déjà été attaché(e) de recherche clinique (ARC) 
  • Un plus si vous avez déjà été chef(fe) de projet clinique

 

Compétences minimum :

  • Expérience d’au moins 3 ans en tant que gestionnaire de données cliniques.
  • Niveau Bac +5 en biologie de la santé (option ingénierie, informatique ou data management) ou en informatique (avec une formation complémentaire en sciences de la vie) ou expérience équivalente
  • Python
  • MySQL

Informations contractuelles

Avantages

  • Congés additionnels 1 RTT par mois
  •  Télétravail 2 à 3 jours par semaine
  •  Mutuelle d'entreprise
  •  Tickets restaurant
  • Participation titres restaurant via Carte Swile (7,50 € dont 60 % de prise en charge)
  • Participation aux frais de transport
  •  Environnement à taille humaine, situé dans le quartier dynamique du 10ème arrondissement de Paris près de République
  •  Être aux premières loges pour participer au développement de nouvelles technologies d’intelligence artificielle dans le domaine de la santé
  •  Être au contact d’une équipe de haut de niveau (X, Centrale, EDHEC, PhD, experts en machine learning, experts en recherche clinique, ex-entrepreneurs…)
  •  Être amené(e) à se voir rapidement confier de nouvelles responsabilités

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