Ludiwine Aeby
Global Clinical Trial Coordinator at Debiopharm- Claim this Profile
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Bio
Credentials
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TRREE Certificate on Good Clinical Practices (GCPs)
TRREEMay, 2018- Nov, 2024 -
LTK Module 1
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Experience
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Debiopharm
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Switzerland
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Global Clinical Trial Coordinator
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Jun 2023 - Present
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HUG - Hopitaux Universitaires de Genève
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Switzerland
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator in Oncology
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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
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CHUV | Lausanne university hospital
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Switzerland
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator, temporary
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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)
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Université de Fribourg - Universität Freiburg
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Switzerland
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Higher Education
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700 & Above Employee
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Graduated Research Assistant
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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
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CHUV | Lausanne university hospital
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Switzerland
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Hospitals and Health Care
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700 & Above Employee
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Master Trainee
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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
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Education
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University of Lausanne - UNIL
Master's degree, Medical Biology -
Université de Fribourg - Universität Freiburg
Bachelor's degree, Biomedical Sciences, General