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Clinical Operations Manager (m/w/d)
Erbe Elektromedizin GmbHTübingen
Als inhabergeführtes Familienunternehmen entwickeln, produzieren und vertreiben wir weltweit chirurgische Spitzentechnologie. Durch unsere zukunftsorientierte Unternehmensführung treiben wir den mediz
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Chief Clinical & Operations Officer
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Amedisys IncKennewickRN - Clinical ManagerMake a difference every day as an Amedisys registered nurse clinical managerJoin Amedisys-one of the largest and most trusted home health and hospice companies in the U.S.-where f
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DSVNew AlbanyOperations ManagerLocation: USA - New AlbanyDivision: SolutionsJob Posting Title: Manager - OperationsTime Type: Full TimePosition Summary:Under the direction of the General Manager, the Operations Ma
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LoomisSacramentoLoomis Armored TransportationWith a network of nearly 200 branches, Loomis armored transportation, cash management centers, and cash inventory vaults keep cash flowing throughout financial institution
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CVS HealthGreenlawnOperations ManagerWe're building a world of health around every individual shaping a more connected, convenient and compassionate health experience. At CVS Health, you'll be surrounded by passionate c
Clinical Operations Manager (m/w/d)
- Tübingen, Baden-Württemberg, Germany
- Tübingen, Baden-Württemberg, Germany
Über
Als inhabergeführtes Familienunternehmen entwickeln, produzieren und vertreiben wir weltweit chirurgische Spitzentechnologie. Durch unsere zukunftsorientierte Unternehmensführung treiben wir den medizinischen Fortschritt voran und leben Werte wie Vertrauen, Respekt und Offenheit. Das ist die Basis unseres Erfolgs.
Für unseren Standort in Tübingen suchen wir für den Bereich Forschung und Grundlagentechnologie einen
Clinical Operations Manager (m/w/d)
- Auswahl und Interaktion mit externen Vendoren (z. B. CRO, EDC-Anbietern)
- Auditierung und Monitoring von Prüfzentren, Co-Monitoring sowie Auditierung der Vendoren
- Leitung und Unterstützung bei der Einreichung von Studienanträgen sowie bei der Verwaltung und Verhandlung von Studienvereinbarungen
- Planung und Durchführung nationaler und internationaler präklinischer und klinischer Studien (nach MDR, GCP, und relevanter ICH-Guidelines, FDA Guidelines) in Zusammenarbeit mit unserem interdisziplinären Forschungsteam und den Abteilungen Qualitätsmanagement und Marketing
- Erstellung von klinischen Prüfplänen, klinischen Studienberichten und wissenschaftlichen Publikationen
- Sicherstellung der regulatorischen Qualitätsanforderungen
- Erstellung von Vorlagen und SOPs für klinische Studien nach u.a. ISO 14155, MDR und FDA Guidelines
- Ansprechpartner für Prüfärzte und ärztliche Kooperationspartner sowie nichtärztliches Personal
- Erfolgreich abgeschlossenes Studium der Humanmedizin, der Humanbiologie oder ein ähnliches naturwissenschaftliches Studium
- Mehrjährige Erfahrung im Monitoring sowie der Einreichung von Studienunterlagen
- Berufserfahrung im Rahmen der Organisation und Durchführung von präklinischen und klinischen Studien
- Gutes Verständnis für regulatorische Anforderungen im Rahmen von präklinischen und klinischen Studien idealerweise für Medizinproduktestudien
- Freude am Arbeiten mit Menschen, Daten und Zahlen in einem internationalen Umfeld
- Ausgeprägte organisatorische und kommunikative Fähigkeiten
- Teamfähigkeit und Flexibilität
- Reisebereitschaft
- Verhandlungssichere Englisch Kenntnisse sowie gute Deutsch Kenntnisse
- Vielfältige Angebote im Gesundheitsmanagement über Kochkurse, Gesundheitstage, Impfkampagnen und Fitnessstudiomitgliedschaften
- E-Ladestationen für E-Autos und kostenlose Parkplätze
- Herausfordernde Aufgaben und viel Eigenverantwortung
- Multikulturelle und internationale Zusammenarbeit sowie Möglichkeit zum agilen Arbeiten
- Attraktive monatliche Vergütung
- Flexible Arbeitszeiten und Möglichkeit hybrid zu arbeiten
- Onboarding mit Einführungsveranstaltung und individuellem Einarbeitungsplan sowie einem breiten internen und externen Trainingsangebot
- Soziale, gesellschaftliche und ressourcenschonende Verantwortung
Sprachkenntnisse
- German
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