Iwona Kolodzinska
Freiburg im Breisgau
Übersicht
13
13
years of professional experience
11
11
years of post-secondary education
1
1
Certification
Berufserfahrung
Clinical Studies Coordinator/ -Assistant
Medical Center Freiburg
Freiburg im Breisgau
2025.02 - 2026.04
- Coordination of clinical studies (feasibility, contracts, financial plans, communication with sponsors)
- Study documentation and patient contact
- Clinical studies assistance
- Department Neurology and Neurophysiology (Multiple Sclerosis and Myasthenia Gravis), Medical Center Freiburg Germany
Documentation/ -Clinical Studies Specialist
Medical Center Freiburg
Freiburg im Breisgau
2023.12 - 2025.01
- Documentation of patient data in GeDoWin, etc.
- Participation in clinical studies TiGER and DefiPace
- Quality Assurance, Department Cardiovascular Surgery, Medical Center Freiburg Germany
Support Laboratory Manager
Pfizer GmbH
Freiburg
2021.04 - 2022.09
- Quality releases, stability studies
- Deputy of Microbiology Lab Manager
- Processing of laboratory/ production failures and deviations (Subject Matter Expert)
- Change Management
QC Assistant
Medinova AG
Zürich
2018.04 - 2019.03
- Quality releases of product and stability documentation
- Operational stability management
- Excel file validation
- Collaboration in development projects
Project JR Microbiologist
Zimmer Biomet GmbH
Winterthur
2014.11 - 2017.06
- Monitoring of sterile products Gamma- EtO- sterilization process qualification
- Preparation of technical documentation/ research reports including trending, statistical data evaluation
- Change management
- Electronic Data Validation of MALDI-TOF spectrometer
QC Microbiologist
ChemCon GmbH
Freiburg
2013.07 - 2014.06
- Method development and validation in the S2 laboratory
- Batch releases
- Processing of OOS/OOL results
- Microbiological monitoring of cleanrooms
- Conducting microbiological analyses in the laboratory
- Preparation of technical documentation
- Preparation for FDA audit
Ausbildung
Certificate of Advanced Studies - Technical Medicine
2018.01 - 2019.12
Diploma in Biology - Microbiology, Cell Biology, Clinical Chemistry, Immunology
2006.10 - 2012.10
Biology Studies - completed basic studies
2002.10 - 2005.10
Kompetenzen
- Microsoft Office
- SAP
- LIMS/gLIMS
- MiniTab
- TrackWise
- GeDoWin QS
- MeDoc
Languages
Polnisch
Muttersprache
German
Fließend (C2)
C2
English
Fachkundig (C1)
C1
Polish
Fließend (C2)
C2
Hobbys
- traveling, cooking, hiking, keeping cats, renovation
Zertifizierung
- Combined Basic and Advanced Supplementary Curse MDR / MPDG Jun 2024
- AMG Introductory curse Dec 2023
- Certificate of Advanced Studies, Technical Medicine Dec 2020
- A22- Stability Management Concept Dec 2018
- Writing a Research Paper for Publication Sep 2016
- M9- Microbiological Data- trending, analysis, statistics May 2015
- DaF Certificate 2006
Zeitleiste
Clinical Studies Coordinator/ -Assistant - Medical Center Freiburg
2025.02 - 2026.04
Documentation/ -Clinical Studies Specialist - Medical Center Freiburg
2023.12 - 2025.01
Support Laboratory Manager - Pfizer GmbH
2021.04 - 2022.09
QC Assistant - Medinova AG
2018.04 - 2019.03
Albert Ludwig University of Freiburg - Certificate of Advanced Studies, Technical Medicine
2018.01 - 2019.12
Project JR Microbiologist - Zimmer Biomet GmbH
2014.11 - 2017.06
QC Microbiologist - ChemCon GmbH
2013.07 - 2014.06
Albert Ludwig University Freiburg - Diploma in Biology, Microbiology, Cell Biology, Clinical Chemistry, Immunology
2006.10 - 2012.10
Jagiellonian University Krakow - Biology Studies, completed basic studies
2002.10 - 2005.10