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Summary

Experienced Clinical Development Professional

Experiences

Current Experience

  • Independent Interim Manager, Consultant and Business Trainer Berlin, Germany
    Since January 2011

    Focus Areas:

    • Clinical Project Management & Team Management
    • Outsourcing & CRO (Contract Research Organization) Management & Oversight
    • Outsourcing Support for Biotechnology Companies
    • Effective Virtual Leadership
    • Service Excellence & Client Relationship Management
    • Process Improvement & Process Harmonization

Past Experience

  • Clinical Research Director / Senior Portfolio Director PAREXEL International, Berlin & London
    April 2006 --- December 2010

    • Management of Global client portfolios
    • Responsibility for operational implementation, quality management, profitability and client relationship management for programs in a portfolio of global key accounts
    • Line management for an international group of project directors for all ongoing projects in portfolio
    • Business development
    • Therapeutic areas in portfolio: Oncology (NSCLC), Pulmonology (COPD), Cardiovascular Disease

  • Worldwide Project Director Düsseldorf, Germany
    July 2005 --- March 2006

    • Project Management for a global 2000-patient phase III study (Type II Diabetes, 17 countries)
    • Review of new proposals
    • Mentoring for project managers
    • Business development support
    • Therapeutic areas: Type II Diabetes, Pulmonary Hypertension

  • CRO Manager & Global Category Manager Berlin, Germany
    December 2001 --- June 2005

    • Development & implementation of a centralized Europe-wide CRO outsourcing function and harmonized procedures for the European Region (Clinical Development)
    • Coordination and harmonization of CRO outsourcing procedures for the regions Europe / USA / Japan
    • Management of the selection and contracting process for the outsourcing of clinical research services for Europe
    • Project lead for consultancy project “Towards Optimal Procurement at Schering”

  • Medical Writer Berlin, Germany
    September 2000 --- November 2001

    • Preparation of investigator brochures, clinical research reports, clinical study protocols, patient information documents
    • Therapeutic areas: Pulmonary Hypertension, Stroke, Parkinson´s Disease, Multiple Sclerosis

     

  • International Project Manager Berlin, Germany
    October 1996 --- August 2000

    • Management of international clinical trials, phases II-III
    • Management of Client contracts
    • Management of Investigator Site Contracts
    • One-month secondment to the Paris office for a process improvement project
    • Therapeutic areas: Alzheimer´s Disease, Vascular Dementia, Deep Fungal Infection, Dermatology

  • Clinical Research Associate (CRA) Frankfurt, Germany
    July 1995 --- September 1996

    • Monitoring and site management for a phase III trial in Type I Diabetes

  • Medical Writer Berlin, Germany
    July 1995 --- July 1996

    • Preparation of clinical research reports, clinical study protocols, patient information documents

Knowledge

Self Assessment :
Diabetes R&DOncology Clinical ResearchCardiovascular diseasesDermatologyEndocrinology and metabolismInfectious diseasesNeurologyPulmonary diseasesRheumatologyRespiratoryOutsourcing

Education

  • M.B.A. in Financial Management from TIAS NIMBAS, Utrecht in 2004
  • Ph.D. in Biochemistry from Freie Universität Berlin in 1996
  • M.Sc. in Chemistry from The Pennsylvania State University in 1993
  • B.Sc., "Vordiplom" in Biochemistry from Freie Universität Berlin in 1989
  • B.Sc. in Preclinical Medicine, "Physikum" from Universität Saarbrücken-Homburg in 1987

Training and Certification

  • Business Trainer in 2011 Certification

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Native
French
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Operations Manager Clinical Project Manager (CPM) Clinical Research Consultant Clinical Research Coordinator Clinical Trial consultant Global PM
  • Work From Home:
    Yes, 2 to 5 days per week
  • Work Regime:
    BrightOwl freelancer :    30-40 Hours per week :    80-90% Free Per Month(in coming months)
  • International:
    Yes

Area / Region

Germany

Others

Driving License
  • Yes