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Wir von der Akkodis Life Sciences besetzen Projekte deutschlandweit für renommierte Kunden in der Pharma-, Biotech-, Chemie-Branche. Von Start-Ups, Familienunternehmen, Mittelständlern, bis hin zu weltweiten Big Playern, haben wir die unterschiedlichsten Kunden und Anforderungen.

Für einen sehr bekanntes Pharma-Unternehmen suchen wir eine:n Assistent:in für klinische Studien (m/w/d).

  • Start: ASAP
  • Standort: Großraum Dresden
  • Auslastung: Vollzeit
  • Direktvermittlung
  • Gehalt: 55.000€ pa

AUFGABEN

  • Organisation und Betreuung klinischer Studien und Zulassungsprojekten für Arzneimittel
  • Zusammenarbeit mit externen CRO's, nationalen und internationalen Koorperationspartnern
  • Kontrolle der weltweiten CRO-Aktivitäten
  • Erstellung, Überprüfung und Archivierung von studien- und zulassungsrelevanten Dokumenten
  • Einhaltung geltender gesetzlicher Bestimmungen für klinische Studien
  • Kontakt mit internationalen Behörden, Ethikkommissionen und Gesundheitseinrichtungen
  • Administrative Aufgaben wie z. B. die Organisation von Konferenzen und Erstellung und Pflege firmeninterner Dokumente des QMS

ANFORDERUNGEN

  • Studium in Pharmazie, Chemie, Biologie, Biochemie
  • Erfahrungen in Projektmanagement und/oder Betreuung klinischer Studien
  • Oder Erfahrung als Klinischer Monitor
  • Erfahrungen in Zulassung von Arzneimitteln von Vorteil
  • Sichere Kenntnisse der Gesetzeslage hinsichtlich klinischer Prüfungen und Zulassung von Arzneimitteln
  • Sichere EDV-Kenntnisse und sehr gute Statistikkenntnisse
  • Sicheres Englisch und Deutsch in Wort und Schrift

Read the full job description and apply online on the recuiter's web-site

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