Dr. Katharina Schaub

ist verfügbar. ✅

Freiberuflich, Clinical Project Manager / Contracts & Outsourcing / Clinical Study Manager, (Freelancer) Dr Schaub - Clinical Research Services
Karlsruhe, Germany

Fähigkeiten und Kenntnisse

Clinical Project Management
Clinical Study Management
CRO & vendor management / outsourcing / contract m
Management / Coordination of Clinical Trials / Bud
Planning / Setup / Surveillance of Clinical Trials
Budget and Contract Negotiations with CROs / site
fast implacement (project / team / corporate)
phase I -IV
Oncology
gene therapy
immunology
Auto-Immune
ATMP
GTMP
Submission of CTAs
SOP-writing / review / govern GCP-SOP project
Development of Clinical Trials Documents
Risk Management in Clinical Trials
Supervision of CROs & third party vendors / Recr
Site Management
Data-warehousing / Oracle databases / implementati
Paediatrics Post Marketing
Argos Credi NovStyle Rave Comas
Projektmanagement
Recherche
Klinische Forschung
Clinical Trial Management
Clinical Research
Pharmaceutical industry
Drug Development
clinical operations management
GCP Requirements
FDA Regulation
Clinical pharmacology
Electronic data capture EDC
CRO management
Contract Management
Contract Negotiation
Vendormanagement
indirect procurement
Financial budgeting
Budget negotiations
clinical trial agreements
Business Process Management
Business process Development
Business Process Design
Business Process Improvement
protocol
regulatory submissions
FDA experience
international business
due diligenes
Change Management
Risk Management
Brain and CNS
biologicals
monoclonal antibodies
Studienkoordination
Over 15 years of experience in pharmaceutical deve
proactive work attitude

Werdegang

Berufserfahrung von Katharina Schaub

  • Current 14 years and 5 months, since Jan 2012

    Clinical Project Manager / Contracts & Outsourcing / Clinical Study Manager

    (Freelancer) Dr Schaub - Clinical Research Services

    Freelance Clinical Project Manager / Senior Clinical Study Manager / Contracts & Outsourcing Manager Eli Lilly & Co (IRE) Ltd - Senior Trial Capabilities Manager // Fresenius Kabi - Senior Clinical Project Manager - FSMP China // Roche Pharma AG CH - Business Manager // Bayer Pharma AG - Contracts Manager // PPD - Contracts Specialist // Quintiles - Contracts Manager // Roche Pharma AG - Contracts & Outsourcing Manager // Grünenthal GmbH - Clinical Manager// Novartis Pharma AG - Expert Clinical Manager /

  • 4 months, Apr 2023 - Jul 2023

    Educational Break étudier le français - Montreal Canada

    ILSC Montreal

  • 1 year, Jan 2011 - Dec 2011

    Expert Clinical Manager

    Novartis Pharma AG, IHC Operations, CBHS (Basel)

  • 2 years and 1 month, Nov 2008 - Nov 2010

    Sabbatical

    Extensive travelling (RSA, Japan, New Zealand, Australia etc.)

    Extensive travelling (RSA, Japan, New Zealand, Australia etc.)

  • 5 months, Jun 2008 - Oct 2008

    Clinical Project Manager

    Biologische Heilmittel Heel GmbH
  • 5 years and 9 months, Oct 2002 - Jun 2008

    (Senior) Clinical Study Manager

    Astellas Pharma GmbH (former Fujisawa Europe) Munich

  • 1 year and 11 months, Sep 2000 - Jul 2002

    Consultant

    IDBS Guildford, Sussex (near London) UK

  • 1 year and 1 month, Jul 1999 - Jul 2000

    Senior Scientist

    Nihon Schering KK Osaka, Japan

  • 1 year and 1 month, Mar 1998 - Mar 1999

    Postdoctoral Researcher

    Schering AG Berlin Germany ( now Bayer Pharma AG )

  • 3 years and 9 months, Feb 1992 - Oct 1995

    Graduate Research Assistant (Studentische Hilfskraft)

    Freie Universität Berlin

Ausbildung von Katharina Schaub

  • 1996 - 2000

    Human medicine

    Freie Universität Berlin, Germany

    Participation at all preclinical practical courses / lectures with exception of Anatomy (all passed with success) until Physikum

  • 2 years and 5 months, Nov 1995 - Mar 1998

    Biology PhD

    Freie Universität Berlin / Schering AG Berlin Germany

    Mechanism of ligand independent and - independent interactions of vitamin D receptor and DNA (PhD scholarship of Schering AG Berlin, now Bayer Pharma AG)

  • 6 years and 1 month, Oct 1989 - Oct 1995

    Biology

    Freie Universität Berlin

    Animal Physiology, Biochemistry & Molecular Biology, Microbiology

  • 2 years and 11 months, Sep 1986 - Jul 1989

    Biology Biol-techn.Assistentin (technian)

    Lise-Meitner-Schule Berlin

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • Japanese

    A1-A2 (Grundkenntnisse)

  • Latein

    B1-B2 (Gute Kenntnisse)

  • Spanish

    A1-A2 (Grundkenntnisse)

  • French

    B1-B2 (Gute Kenntnisse)

  • Russian

    A1-A2 (Grundkenntnisse)

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