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Clinical Data Manager

vor 2 Monaten


Munich, Bayern, Deutschland Deutsches Herzzentrum München Vollzeit
Ihre Aufgaben

Wir suchen einen Clinical Data Manager, der sich auf die Durchführung klinischer Studien zu Herz- und Kreislauferkrankungen spezialisiert hat. Als Teil des ISAResearch Center werden Sie in der Forschungsgruppe tätig sein und sich auf die Unterstützung bei der Durchführung klinischer Studien konzentrieren.

Ihre Hauptaufgaben
  • Durchführung des klinischen Data Management in Übereinstimmung mit dem Prüfplan, ICH-GCP, SOPs und regulatorischen Anforderungen
  • Erstellung von elektronischen Case Report Forms (CRF) inklusive Edit Check Spezifikationen
  • Management und Durchführung von Data Cleaning, Data Validation, Queries und Plausibilitätskontrollen
  • Datenbankerstellung/-überarbeitung sowie Definition, Programmierung und Validierung von Data Listings
  • Koordination und Durchführung von User Acceptance Tests (UAT)
  • Data Management Dokumentation wie Data Validation Plan (DVP), Data Management Plan (DMP), Reports etc.
  • Training von Studienmitarbeitern
  • Teilnahme an Audits und Inspektionen
Ihr Profil

Wir suchen einen engagierten und erfahrenen Clinical Data Manager, der über eine fundierte Ausbildung im Bereich eHealth-IT, Medizinische Dokumentation/Informatik, Gesundheitsinformatik, Informationsmanagement im Gesundheitswesen, Data Science in der Medizin oder einer vergleichbaren Qualifikation verfügt. Erfahrung mit Datenbanken sowie medizinischen Dokumentationssystemen ist erforderlich. Regulatorische Anforderungen im Datenmanagement bei klinischen Studien (ICH/GCP) sollten bekannt sein. Fundierte Office-Kenntnisse (insbesondere Excel, Access) sind erforderlich. Kenntnisse von XML, SQL und SAS Programmierung sind von Vorteil. Hohes Maß an Verantwortungsbewusstsein, Selbständigkeit und Organisationstalent ist erforderlich. Gute Kommunikationsfähigkeit in Kombination mit Teamfähigkeit und Flexibilität ist erforderlich. Sehr gute Englisch- und Deutschkenntnisse (mündlich/schriftlich) sind erforderlich.

Unser Angebot

Wir bieten einen zunächst auf zwei Jahre befristeten Arbeitsvertrag mit Perspektive auf Weiterbeschäftigung. Eine sehr interessante berufliche Herausforderung in einem universitär und international geprägten Umfeld. Vergütung nach dem TV-L (inkl. Jahressonderzahlung). Fort- und Weiterbildungsangebote. Betriebliche Altersvorsorge/Betriebsrente. Personalrestaurant. Mit unserem Firmen-Fitnesspartner EGYM Wellpass unbegrenzt in über 6.000 Sport- und Gesundheitseinrichtungen deutschlandweit trainieren. Zahlreiche Rabattmöglichkeiten für unsere Mitarbeitenden über das Vorteilsprogramm corporate benefits, Fahrrad-Leasing mit JobBike Bayern und andere Vergünstigungen.

Das Deutsche Herzzentrum München fördert aktiv die Gleichstellung aller Mitarbeiter und Mitarbeiterinnen. Wir begrüßen deshalb Bewerbungen von Männern und Frauen, unabhängig von deren kultureller und sozialer Herkunft, Alter, Religion, Weltanschauung, Behinderung oder sexueller Identität. Bewerber und Bewerberinnen mit Schwerbehinderung werden bei gleicher Eignung unter Berücksichtigung aller Umstände des Einzelfalls bevorzugt.