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Clinical Data Manager
3 days ago
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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