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Clinical Operations Manager (m/w/d)
Erbe Elektromedizin GmbHTübingenAls inhabergeführtes Familienunternehmen entwickeln, produzieren und vertreiben wir weltweit chirurgische Spitzentechnologie. Durch unsere zukunftsorientierte Unternehmensführung treiben wir den mediz
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Operations Manager
Courtyard Potomac MillsVirginiaCompensation Type: Yearly Highgate Hotels: Highgate is a leading real estate investment and hospitality management company with over $15 billion of assets under management and a global portfolio of mo
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SRS Building Products - BendOregonPosition Purpose:The Operations Manager at the Company plays a pivotal role in ensuring the efficient and accurate management of warehouse functions, including the supervision of drivers, loaders, and
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PathForwardArlingtonOperations ManagerThe Operations Manager is responsible for overseeing and optimizing the day-to-day administrative and operational functions of PathForward. This role ensures that office operations a
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CVS HealthBronxOperations 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
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Raising Cane'sGrand RapidsOperations Manager (OM)At Raising Cane's Chicken Fingers, we serve only the most craveable chicken finger meals it's our One Love! Known for our great Crew and cool Culture, we follow a Work Hard. Hav
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Thompson Street Capital PartnersNeedhamRevenue Operations ManagerOpenClinica enables organizations to recruit participants and conduct clinical studies through connected solutions that simplify operations and accelerate discovery. Our plat
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Healthcare Analytics & Operations Manager
Highmark HealthBaton RougeHighmark Health in Baton Rouge, Louisiana is seeking an experienced individual to oversee daily operations of the department. The role involves leading the development of analytical dashboards and rep
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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