Ludiwine Aeby

Global Clinical Trial Coordinator at Debiopharm
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Contact Information
us****@****om
(386) 825-5501
Location
Lausanne, Vaud, Switzerland, CH

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Credentials

  • TRREE Certificate on Good Clinical Practices (GCPs)
    TRREE
    May, 2018
    - Nov, 2024
  • LTK Module 1
    -

Experience

    • Switzerland
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Global Clinical Trial Coordinator
      • Jun 2023 - Present

    • Switzerland
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Research Coordinator in Oncology
      • Dec 2018 - May 2023

      - Review of clinical trial agreements between site and Sponsor - Site pre-selection, initiation, monitoring and close-out visits; collaboration with Sponsor/CRO for submissions to regulatory authorities - On-site implementation of complex phase I, phase II and phase III protocols, including coordination of all involved site departments and creation of study specific data source document templates - Ensuring data integrity through ALCOA principles throughout the study - ISF set-up, maintenance and archiving - Reception, storage, allocation and accountability of IMPs - Implication in safety reporting ; reception and transmission of SUSARs to study team - Use of IWRS and various vendors online platforms - eCRF data entry ; data cleaning - Processing, storage and shipment of biological samples - Study site invoicing management - Preparation of audits, creation and implementation of CAPA plans - QA: participation in redaction and review of internal SOPs Show less

    • Switzerland
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Research Coordinator, temporary
      • May 2018 - Nov 2018

      - Coordination of clinical trials in oncology - Communication with Sponsor, (co-)investigators and study nurses - Patient safety (AEs and SAEs) - Filling of CRFs - Deviations (CAPA plans) - Coordination of clinical trials in oncology - Communication with Sponsor, (co-)investigators and study nurses - Patient safety (AEs and SAEs) - Filling of CRFs - Deviations (CAPA plans)

    • Switzerland
    • Higher Education
    • 700 & Above Employee
    • Graduated Research Assistant
      • Mar 2016 - Dec 2017

      - Fundamental research in the field of neuroscience using histological techniques - Assistant teaching duties in practical histology courses for undergraduate students - Fundamental research in the field of neuroscience using histological techniques - Assistant teaching duties in practical histology courses for undergraduate students

    • Switzerland
    • Hospitals and Health Care
    • 700 & Above Employee
    • Master Trainee
      • Apr 2015 - Jan 2016

      - Implication in the in vivo efficacy assessment of designed viral vectors (surgery, histology, data analysis) in the context of neurodegenerative disease - Implication in the in vivo efficacy assessment of designed viral vectors (surgery, histology, data analysis) in the context of neurodegenerative disease

Education

  • University of Lausanne - UNIL
    Master's degree, Medical Biology
    2014 - 2016
  • Université de Fribourg - Universität Freiburg
    Bachelor's degree, Biomedical Sciences, General
    2011 - 2014

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