Heike Kovar

ist offen für Projekte. 🔎

Angestellt, Clinical Trial Oversight Manager, Amgen GmbH
München, Germany

Fähigkeiten und Kenntnisse

Functional Service Provider Management
Ressource Management & Risk Mitigation
Risk based monitoring
Ethics Committee Submissions
CRA Management
CTA Management
Contract Management
Pharmaceutical Law/ Healthcare Compliance/Contract
Experienced with Audits and Inspections
CAPA Design & Implementation
Quality Assurance Management
Risk Management
Change Management
Key Performance Metrics
Team Recruitment Training & On-Boarding
Process optimisation
Stakeholder Relations
Vertragsgestaltung

Werdegang

Berufserfahrung von Heike Kovar

  • Current 11 years and 6 months, since Jan 2015

    Clinical Trial Oversight Manager

    Amgen GmbH

    Functional Mangement and oversight of FSP Partner for CTAs and CRAs, LM ( 50 + high professionals) regarding study deliverbles, performance and quality with focus on proactive risk mitigation ensuring that KPI and metrics are met sucessfully. Additionally I serve as direct Line Management for Contract Managers (~6) responsible for supervision of clinical trial contracts and budgets to ensure timely set up of clinical sites and compliance with fair market value and applicable laws and regulations.

  • 3 years and 3 months, Oct 2011 - Dec 2014

    Manager Clinical Research Services

    Amgen GmbH

    Head of Clinical Research Services (CTAs, Projektmanager, Contract Manager)

  • 1 year and 9 months, Jan 2010 - Sep 2011

    Healthcare Compliance Manager

    Amgen GmbH
  • 1 year and 7 months, Jun 2008 - Dec 2009

    Senior Clinical Contract Specialist

    PPD Gmbh & Co KG

  • 1 year and 2 months, Apr 2007 - May 2008

    Senior Consultant

    DOCS International Germany GmbH

  • 2 years and 9 months, Jul 2004 - Mar 2007

    Senior European Contract Manager

    GE Healthcare Buchler GmbH

  • 1 year and 6 months, Jan 2003 - Jun 2004

    CTA

    GE Healthcare Buchler GmbH

  • 1 year and 4 months, Sep 2001 - Dec 2002

    Assistant Clinical Research and Development

    Morphosys AG
  • 8 months, Jan 2001 - Aug 2001

    Assistant Clinical Research and Development

    Genetics Institute GmbH

Ausbildung von Heike Kovar

  • Bis heute

    Rechtswissenschaft

    Universität Augsburg

    Arbeits und Sozailrecht

Sprachen

  • German

  • English

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

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