Dr. Sandra Karitzky
Angestellt, Director Global Clinical Operations, Miltenyi Biomedicine GmbH
Bergisch Gladbach, Deutschland
Über mich
Extensive experience in program management, resourcing (tactical and strategic) and in creating new organizational structures, building and motivating cross-functional international clinical research teams and strategically aligning them across multiple portfolios (CGT, medical devices, transplantation, and epidemiology studies) in a dynamic and results-oriented environment. Natural ability to inspire and lead teams to achieve their full potential. Supportive and goal-oriented combined with a deep understanding of product and process quality and risk management processes, tools and methodologies. Drove and shaped the development of an audit-proven, GXP-compliant clinical development process and governance landscape for pharmaceuticals and medical devices.
Werdegang
Berufserfahrung von Sandra Karitzky
Bis heute 3 Jahre und 2 Monate, seit Mai 2021
Director Global Clinical Operations
Miltenyi Biomedicine GmbH
program management, tactical and strategic resourcing, building organizational structures for international drug/device development matrix teams, managing/hiring clinical research staff, supporting clinical research portfolio reporting, developing and optimizing processes in local and global projects.
3 Jahre und 4 Monate, Okt. 2019 - Jan. 2023
Quality Assurance Contact - Clinical Research & Development
Miltenyi Biomedicine GmbH
1 Jahr und 7 Monate, Okt. 2019 - Apr. 2021
Group Leader Clinical Trial Management
Miltenyi Biomedicine GmbH
Managing team of >10, including Clinical Trial Leads across assets (early, late stage); CART, medical devices, epidemiological studies, resource management; developing/enabling processes across teams; ensuring compliance to standards/regulations
4 Jahre und 9 Monate, Jan. 2015 - Sep. 2019
Clinical Trial Manager
Miltenyi Biotec GmbH
16 Jahre und 9 Monate, Jan. 2003 - Sep. 2019
Quality Assurance Representative
Miltenyi Biotec B.V. & Co. KGDevelopment and maintenance of a SOP and training system in Clinical Development according to GCP and other regulatory requirements in Europe
5 Jahre und 4 Monate, Sep. 2009 - Dez. 2014
Clinical Project Manager
Miltenyi Biotec GmbH
6 Jahre und 8 Monate, Jan. 2003 - Aug. 2009
Manager Medical Development
Miltenyi Biotec GmbH
1 Jahr, Jan. 2002 - Dez. 2002
Clinical Research Associate
Miltenyi Biotec GmbH
1 Jahr, Jan. 2001 - Dez. 2001
Product Manager
Schebo Biotec
Ausbildung von Sandra Karitzky
3 Jahre und 2 Monate, Nov. 1997 - Dez. 2000
Immunology
University of Tubingen
Stem cell mobilisation, hematopoietic microenvironment
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Deutsch
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Englisch
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