Katrin Falkhofen

Clinical Operations Managerin, Pharma, Biotech, Generics

München, Deutschland

Fähigkeiten und Kenntnisse

7 years experience within international Regulatory
3 years experience as CRA
11 years experience within global CROs and Pharmac
Expert knowledge of national and international reg
Expert knowledge of international regulatory proce
Line Management experience/ direct reports
Excellent decision making skills
Teamdeveloper
Teammotivator
Trainer skills

Werdegang

Berufserfahrung von Katrin Falkhofen

  • Clinical Operations Managerin

    Pharma, Biotech, Generics

    Responsibility for execution and oversight of clinical trial country submissions and approvals for assigned protocols Development of local language materials including local language Informed Consents and translations Partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols Responsibility for managing country deliverables, timelines and results for assigned protocols

  • Senior Site Start Up & Regulatory Specialist

    INTERNATIONAL CRO

  • Clinical Submission Specialist

    INTERNATIONAL CRO

    Performance and coordination of clinical study submissions within Regulatory Affairs Responsibility for study start-up process

  • CRA I & II

    INTERNATIONAL CRO

    Clinical Research Associate I & II

Ausbildung von Katrin Falkhofen

  • 3 Jahre und 2 Monate, Sep. 1996 - Okt. 1999

    Humanmedizin

    Ludwig-Maximilian-Universität München

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Fließend

Interessen

Sailing
Goldsmithing
Fine Arts
Travelling

21 Mio. XING Mitglieder, von A bis Z

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