Business System Expert Oracle Clinical One EDC

Il y a 2 semaines
Saclay, Ile-de-France Infogene Temps plein
Business System Expert Oracle Clinical One EDC Département Clinical System Management | Data Acquisition Contexte de la mission Dans le cadre de sa transformation digitale, un acteur de l’industrie pharmaceutique renforce son équipe Clinical System Management (CSM). Le consultant contribuera à la performance et à l’adoption des applications utilisées pour collecter les données des essais cliniques. Il travaillera en binôme avec un autre Business System Expert, principalement sur Oracle Clinical One EDC, en lien étroit avec les équipes Clinical Data Management (CDM), la DSI et les utilisateurs métier. Responsabilités Assurer le suivi des incidents techniques avec les équipes DDIS et coordonner leur résolution. Recueillir les besoins des utilisateurs, les formaliser et les représenter auprès de la DSI et des parties prenantes. Superviser les activités opérationnelles et l’administration fonctionnelle de l’application. Participer aux déploiements, aux évolutions et à la validation du système ; maintenir la documentation qualité à jour. Former et accompagner les utilisateurs afin de faciliter l’adoption d’Oracle Clinical One. Suivre l’utilisation de l’outil, analyser les écarts et proposer des actions correctives et préventives (CAPA). Contribuer au cadrage de nouveaux projets : besoins métier, parties prenantes, processus impactés, ressources, risques et dépendances. Livrables attendus Documentation de validation des systèmes informatisés et rapports de qualification opérationnelle (OQ). Reporting hebdomadaire des demandes de support, de leur typologie et des CAPA proposées. Comptes rendus de réunion et dossiers de cadrage des nouveaux projets.

Profil recherché
Formation Bac +5 scientifique ou diplôme d’ingénieur. Deux à cinq ans d’expérience en gestion de systèmes applicatifs, idéalement dans les essais cliniques. Expérience concrète dans la gestion d’un EDC ; la connaissance d’Oracle Clinical One est particulièrement recherchée. Connaissance de la recherche clinique, des réglementations ICH-GxP et de la validation des systèmes informatisés (CSV). Anglais courant à l’écrit et à l’oral ; aisance relationnelle, écoute et capacité à expliquer simplement des sujets techniques. Sens du service, orientation solutions et ouverture d’esprit ; expérience en gestion de projet appréciée. Modalités Démarrage souhaité : 5 octobre 2026. Présence sur site à Saclay : deux à trois jours par semaine.

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