Clinical and Translational Scientist / CRA
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- 72074 Tübingen
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- 12.12.2023
Kurzvorstellung
scientific expertise in Oncology, Immunologie-Oncology,
ISO 13485, ISO 15189, Iso 14917, IVDR
study site / vendor management and oversight
scientific and medical writing
strategic thinking, solution orientated
Qualifikationen
Projekt‐ & Berufserfahrung
2/2023 – offen
Tätigkeitsbeschreibung
-Review of clinical study plans / performance studies of diagnostic devices
-site vistits (study start up/ closure)
-data review and completeness checks
-study management
-guideline compliant working
-contact point to regulatory authorities
Medical Writing, Gesundheitswesen, Good clinical practice (GCP), Scientific computing / wissenschaftliches Rechnen
5/2022 – 10/2023
Tätigkeitsbeschreibung
-Management of the Clinical Team
-planning of performance studies for diagnostic devices
-planning and set up of QC processes for diagnostic deviceT troubleshooting of process
-set up of SOP
-support of daily business
Good clinical practice (GCP), Management (allg.), Teamentwicklung
4/2021 – 12/2023
TätigkeitsbeschreibungCRO Management, Vendormanagement, bioanalytical support based on guidelines, scientific support for multiplex ligand binding platform, support of clinical development Phase I-IV
Eingesetzte QualifikationenGood clinical practice (GCP), Gute Herstellungspraxis (GMP), Projektmanagement - Projektentwicklung
7/2019 – 12/2020
Tätigkeitsbeschreibung
assay development for platform processes, Teamlead, grant writing, writing of scientific publications, data analysis and summary in form of reports and ppt, representation of the department in meetings with customers or scientific partners
clinical development & automatization
Gute Herstellungspraxis (GMP), Medical Writing, Projektleitung / Teamleitung, Projektmanagement - Projektentwicklung
7/2017 – 6/2019
Tätigkeitsbeschreibung
lead technology development, supervision, team lead, assay development
process intensification and optimization, process improvements
Pharmaforschung, Projekt-Arbeitsvorbereitung, Projekt-Dokumentation, Projektdurchführung, Qualitätsmanagement (allg.)
10/2002 – 12/2016
Tätigkeitsbeschreibung
Project development, Project Lead, scientific writing: publications, grant writing, and report writing, representation of work results at national and international conferences, academic teaching (seminars, lectures)
planning and execution of experimental work, troubleshooting and solutions for experimental set ups and scientific questions, data analysis and interpretation
Gute Laborpraxis (GLP), Pharmaforschung
Ausbildung
Greifswald
Über mich
-over 3 years experience in clinical studies (Pharma and IVDR)
-working as subject matter expert in phase I-III, including writing and review of study plans and reports, vendor oversight and management,
-QC of analytical data and set up of validation strategies for Biomarkers
-experience with performance studies according to IVDR
-experience as Clinical scientist/ CRA: study site management/ oversight, data review according to guidelines and SOP
-contact to regulatory authorities
-broad hand on experience in several biological, molecular technologies (Flow Cytometry, LBA, Cell culture, Viral work, animal studies, DNA/ RNA, IHC)
Weitere Kenntnisse
-MQ1 certificate (Medizindidaktische Fortbildung)
-GcP practice
-Project management
-4GenTSV biological safety for projectmanagers
Personal:
-Innovative research: from idea to result
-broad experience: cell therapy (CAR-T and NK cells), oncology (tumor resistance & generation, cancer stem cells) antibody development, immune-oncology
-GMP compliant work
-scientific writing: publications, reports, grants, TVV, SOPs, ppt etc.
-assay development: phenotypic and functional from idea to protocols
-work with industrial partners
-project lead & management: in all aspects (scientific and coordinating)
-set up and structuring of research labs: GMP-Development Unit, S2 labs
-teaching: oncology and inflammation, cancer stem cells, cell line development
process intensification
Persönliche Daten
- Deutsch (Muttersprache)
- Europäische Union
- Schweiz
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