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.

Fähigkeiten und Kenntnisse

Klinische Forschung
Klinische Studien
Qualitätsmanagement
Drug Development
Ressource & Budget Management
Projektmanagement
Personalführung
Clinical Research
Cell and Gene Therapy
GxP
Hematology
Oncology
Stem Cell Transplantation
Medical Devices
Process & Risk Management

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. KG

    Development 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

Sprachen

  • Deutsch

    -

  • Englisch

    -

21 Mio. XING Mitglieder, von A bis Z