Caroline Laemmli

Scientific Collaborator - Medical Devices Clinical Investigations at Swissmedic
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Contact Information
us****@****om
(386) 825-5501
Location
Switzerland, CH
Languages
  • English Native or bilingual proficiency
  • French Native or bilingual proficiency
  • German Native or bilingual proficiency

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Experience

    • Switzerland
    • Government Administration
    • 200 - 300 Employee
    • Scientific Collaborator - Medical Devices Clinical Investigations
      • Aug 2022 - Present

      Evaluation of pre-market clinical studies with medical devices for delivery of authorisation to perform study. Monitoring of ongoing studies, serious adverse events and device deficiencies, as well as evaluation of amendments and inspections of ongoing studies. Evaluation of pre-market clinical studies with medical devices for delivery of authorisation to perform study. Monitoring of ongoing studies, serious adverse events and device deficiencies, as well as evaluation of amendments and inspections of ongoing studies.

    • Switzerland
    • Medical Equipment Manufacturing
    • 200 - 300 Employee
    • Investigator Initiated Trial Program Manager
      • Jan 2021 - Jun 2022

      Implementation of the review process for Investigator Initiated Studies Overall responsible of the IIT program (process owner) Pre-review study proposals, coordination of the review process Liaison and leading the responsible person in affiliates Overseeing advancement of studies Responsible budget and contract negotiations Process improvement

    • Clinical Research Manager (GCP)
      • Mar 2018 - Dec 2020

    • Switzerland
    • Biotechnology Research
    • 1 - 100 Employee
    • Senior Quality Manager (GMP)
      • Oct 2015 - Jan 2018

      Support of research groups in the phase of pre-clinical testing (GLP) and regulatory questions (GxP). Support of research groups in the phase of pre-clinical testing (GLP) and regulatory questions (GxP).

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Study Director Bioanalytics (GLP)
      • Jan 2011 - Aug 2015

    • Quality Assurance Auditor (GLP)
      • Apr 2008 - Dec 2010

    • Switzerland
    • Research Services
    • 700 & Above Employee
    • Executive officer / Coordinator
      • Jun 2005 - Mar 2008

    • Post-Doc
      • Feb 2003 - Jun 2005

    • Research Associate Group Ecotoxicology
      • Oct 2001 - Sep 2002

Education

  • Clinical Trial Center Zürich
    Certificate of Avanced Studies (CAS), Clinical Trial Management
    2016 - 2016
  • Eidgenössische Technische Hochschule Zürich
    PhD, Molecular environmental microbiology
    1997 - 2001

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