Clinical Supplies Project Associate
vor 3 Wochen
Wir suchen einen motivierten und zielstrebigen Projektmitarbeiter, der sich in der Bereitstellung von klinischen Prüfmustern auskennt.
Ihre Aufgaben:- Unterstützung und Zuarbeiten der Projektmanager bei der Bereitstellung klinischer Prüfmuster
- Zentraler Ansprechpartner für die gesamte Projektgruppe für standardisierte Tätigkeiten für verschiedene globale klinische Studien (Phase 1 bis 4)
- Mitarbeit bei der Planung, Organisation und Koordination von Prüfmustern für die Durchführung klinischer Studien durch:
- Erstellung des Auftrags zur Verpackung und Etikettierung von klinischen Prüfmustern im Warenbewirtschaftungssystem (Manufacturing Request)
- Initiierung damit verbundener Zusatzaktivitäten
- Unterstützung der Projektmanager bei Laufzeitverlängerung von klinischen Prüfmustern
- Unterstützung bei Um-/Überarbeitung von klinischen Prüfmustern, falls erforderlich
- Kommunikation mit den relevanten Schnittstellen (Verpackung, Label-Team, TEG-Gruppe, QA, Warenlager und Versand) bei Unklarheiten oder Änderungen von Zeitlinien
- Mitarbeit bei der Erarbeitung neuer Konzepte und Strategien rund um die Bereitstellung von klinischen Prüfmustern
- Mitarbeit in lokalen Projektteams
- Teilnahme und Präsentation von Konzepten in lokalen und auch globalen Projektteams
- Mitarbeit bei der Erstellung und Überarbeitung von GMP- und GCP relevanten SOPs
- Erfolgreich abgeschlossene naturwissenschaftliche oder heilberufliche Ausbildung (Bachelor oder duales Studium)
- Strukturierte Arbeitsweise und selbständige Organisation des Arbeitsalltags
- Grundkenntnisse im Projektmanagement
- Erfahrung im Bereich der Entwicklung oder im GMP/GCP Umfeld
- Kenntnisse der GMP/GCP-Regularien
- Zielorientierte und selbständige Arbeitsweise
- Sehr gute englische Sprachkenntnisse
- Sehr gute EDV-Kenntnisse
- Sehr gute Team- und Kommunikationsfähigkeiten
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