Dr. Michal Wysocki
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Michal Wysocki
- Bis heute 2 Jahre und 6 Monate, seit Dez. 2022
Director Site Management and Monitoring (Therapy Area Lead/Line Manager)
AstraZeneca GmbH, Hamburg, Germany
Oncology, phase I-III Resources management Development and performance management Contributing to efficient organization of the TA and its functioning at country level, Successful delivery of country level targets including forecasting the recruitment and study timelines, cross-functional cooperation within the company (Medical Affairs, Commercial, Global Teams) and with external stakeholders Supporting the high quality feasibility work, quality improvement of the study processes and other procedures
- 2 Jahre und 2 Monate, Okt. 2020 - Nov. 2022
Local Study Associate Director (Local Study Manager, DACH)
AstraZeneca GmbH, Hamburg, Germany
Oncology, phase I-III studies Project management activities in start-up, maintenance and close-out phase RA/EC submissions, BfS submissions, ICF adaptation, site contracts and budget negotiations Study oversight, monitoring of the study status using various functionalities and systems (CTMS, eTMF, IRT, eCRF, study specific and vendor provided portals) Maintaining the study budget Mentoring and training activities, guidelines preparation, supporting and supervising CTAs and CRAs in study specific activities
- 2 Jahre und 1 Monat, Sep. 2018 - Sep. 2020
Centralized Monitoring Therapy Area Lead (Risk Manager)
AstraZeneca Pharma Poland Sp. z o.o., Warsaw, Poland
Therapy Areas: Oncology, Respiratory, phase I-IV studies Risks management: identification and assessment of risks, defining critical to quality factors, cross-functional coordination, project management activities Centralized monitoring on study, country and site level Authoring Risk Management Plan, preparing various functional plans and trainings
- 8 Monate, Dez. 2017 - Juli 2018
Clinical Research Associate II
Syneos Health for AbbVie Polska Sp. z o.o., Warsaw, Poland
Immunology, phase II study on-site monitoring, remote monitoring, site management contract management
- 1 Jahr und 1 Monat, Nov. 2016 - Nov. 2017
Site Manager (Clinical Research Associate)
DOCS International Poland Sp. z o.o. for Janssen-Cilag Polska, Warsaw, Poland
Psychiatry, phase III studies on-site monitoring site management
- 7 Monate, Apr. 2016 - Okt. 2016
Clinical Research Associate
Dokumeds SIA, Sp. z o. o., Warsaw, Poland
Oncology phase III and IV studies Haematology phase IIb/III paediatric study on-site monitoring, site management RA/EC submissions site feasibility, site selection finance and site contracts related activities
- 11 Monate, Mai 2015 - März 2016
Junior Clinical Research Associate
Dokumeds SIA, Sp. z o. o., Warsaw, Poland
Oncology phase III and IV studies - on-site monitoring, site management, RA/EC submissions, site feasibility, site selection, finance and site contracts related activities Gastroenterology phase II, Neurology phase II - in-house activities, RA/EC submissions, on-site monitoring activities (supervised), site contracts quality review
Ausbildung von Michal Wysocki
- 2003 - 2006
Dr. rer. nat., Technical University of Munich, Freising-Weihenstephan, Germany
- 1997 - 2003
M.Sc., Eng., Poznan University of Life Sciences, Poland
Sprachen
Polnisch
Muttersprache
Englisch
Fließend
Deutsch
Fließend
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