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Over 25 years experience in Clinical Operations, from Medical Writing through CRA/CRM to Director Clinical Operations (pharma/biotech).

  • Member of taskforce to harmonize and standardize processes/documents for Clinical Development across branches of large pharmaceutical company.
  • Organized and supervised local and international Phase I-III trials, including Orphan Indication, mainly in (but not exclusive)
    • Rheumatoid Arthritis
    • Multiple Sclerosis
    • Dermatology
      • atopy
      • lamellar ichthyosis
      • psoriasis
      • ...
    • Allergies (rhinitis, conjunctivitis)
    • Cachexia
    • ...
  • Set-up Clinical Operations Department in starting biotechs.
  • Coordinated (GxP) Quality Management System and Document Management System set-up.

Experiences

Past Experience

  • Associate Director Clinical Operations

    November 2012 --- October 2013

  • Senior Manager Clinical Operations

    June 2008 --- September 2012
    Clinical trials

  • Director Clinical Operations EUR

    April 2002 --- March 2008

  • CRM

    January 1982 --- January 2001

  • CRA/CRM

    January 1982 --- January 1997

Knowledge

LinkedIn Assessment :
Clinical trialsClinical researchmanagementClinical operationsClinical DevelopmentoncologyPharmaceutical IndustryDrug DevelopmentBiotechnologyImmunologyRegulatory affairsCROCTMSGCPICH-GCPLifesciencesSOPBiomarkersR&DInfectious diseasesBiopharmaceuticalsClinical monitoringElectronic Data Capture (EDC)

Education

  • Certificate in Italian from Centre for Adult Education (evening classes) in 2010
  • Master in Translation, English & Spanish from HIVT (RUCA) in 1981

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
Spanish
Professional Proficiency
Italian
Elementary Proficiency
French
Professional Proficiency
German
Elementary Proficiency

Work Preferences

  • Locations I am interested in:
    Aachen, Germany Antwerp, Belgium Brussels, Belgium Limburg, Belgium Limburg, Netherlands North Brabant, Netherlands
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer :    40 Hours per week
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Herenthout

Others

Driving License
  • Yes

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