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Experiences

Current Experience

  • Global Snr. Site StartUp & Regulatory Project Manager


    Since September 2014

Past Experience

  • Global Study Start-Up Team Lead

    November 2012 --- July 2014
    full service provider to all aspects of global start-up in accordance to sponsor specifications for Clinical trials. my role is to develop, evaluate and execute all essential Clinical Trial documents, e.g. prepare and approve patient Informed Consent forms, review and approve Clinical Trial agreements (cta’s) and related documents between sponsors and Clinical Trial sites. interacts with global irb sites and ssu associates, align execution activities with agreed upon project priorities, timings and quality specifications. review important regulations, to develop proactive solutions to start-up issues and challenges and to ensure relevant regulations are adhered including ich and phrma guidelines. my work is performed in Compliance with all internal requirements and all applicable global regulatory requirements (north & latin america, eu and apac countries).

  • Clinical Operations Lead

    January 2011 --- November 2012

  • Principal CRA

    January 2003 --- January 2010

  • Principal CRA

    January 2003 --- January 2010

  • Advanced CRA

    June 2003 --- January 2005

  • Clinical Research Site Manager, CRSM

    January 2000 --- February 2003
    Clinical research department stockholm sweden

  • Laboratory Engineer

    January 1996 --- December 1997

  • Laboratory Engineer

    January 1995 --- January 1996

  • Laboratory Engineer

    January 1989 --- January 1992

  • Laboratory Technician

    February 1989 --- January 1990
    department of tuberculosis, involved in preparing cultures, and verifying and identifying different tuberculosis Bacteria specimens from the entire the world with maximum safety and reliability.

  • Laboratory Technician

    January 1988 --- January 1988
    Planning, analyzing and identifying chromosome culture, amniocentesis and biopsy specimens for typing of various diseases and sexing.

Knowledge

LinkedIn Assessment :
Clinical trialsCTMSClinical monitoringGCPPharmaceutical IndustryCROClinical researchClinical DevelopmentTherapeutic AreasVaccinesClinical operationsPharmacovigilanceICH-GCPoncologyRegulatory submissionsEDCDrug DevelopmentRegulatory RequirementsClinical Data ManagementNeurologySOP

Education

  • Bachelor of Applied Science (B.A.Sc.) in Biology/Biological Sciences, General from West Visayas State University in 1986
  • in from Negros Occidental High School in 0000

Area / Region

Stockholm, Sweden

Others

Driving License
  • No

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