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Letztes Update: 04.11.2022

Senior Clinical Research Associate

Abschluss: Medical IT
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (gut) | italienisch (Grundkenntnisse)

Dateianlagen

Km_SeniorCRA_Triallisting.pdf
KM_SeniorCRA_Profile_Confidential.pdf

Skills

Eight years experience in Clinical Trial Monitoring DACH Region
Phases I-IV & non-interventional
ONCOLOGY NEUROLOGY DERMATOLOGY RHEUMATOLOGY

All visit types: Feasibility - Initiation - Interim - Close-out;
Site Management; ICH-GCP ; AMG; Site Management;
Audit preparation; CAPA; Quality Review & Protocol Deviation Management;
EC/Swissmedic Submissions 

Projekthistorie

10/2020 - 08/2022
Senior CRA - Oncology/Immunology - all phases - SWITZERLAND
Pharmaceutical Switzerland (Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)

SIV - Interim Monitoring - Close-out
Issue Management & CAPA
Management of Site Visits
eTMF QC check
Mentoring/Training of Junior CRA

10/2019 - 08/2020
Clinical Monitor - Oncology - Phase 3 - SWITZERLAND
AbbVie Switzerland (Pharma und Medizintechnik, 500-1000 Mitarbeiter)

All visit types (Feasibility, Initiation, Interim, Closure Visits)
Monitoring accross SWITZERLAND (D & FR speaking sites)
Swissmedic/EC Submissions
Site Management (Issues, Reporting, CAPA)
Data Cleaning
Site staff training

01/2016 - 10/2019
CRA DERMATOLOGY Phases III-IV - Germany fieldbased
CRO Germany fieldbased (Pharma und Medizintechnik, 500-1000 Mitarbeiter)

Monitoring 
Data Cleaning
Reporting
Ensuring trial conduct acc. to AMG+ICH-GCP

06/2015 - 12/2015
Clinical Trial Support / CTA
Clinical Consulting Germany (Pharma und Medizintechnik, 50-250 Mitarbeiter)


09/2013 - 03/2015
Research Monitor intern. multicenter observational trials
European Huntington Research (50-250 Mitarbeiter)

Monitoring of Phase II & NIS
Train-the-Trainer
EC submissions
Data Management 
Language Coordinator Tasks
Project Support

Reisebereitschaft

Weltweit verfügbar
Profilbild von Anonymes Profil, Senior Clinical Research Associate Senior Clinical Research Associate
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