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Summary

11 years experience working in Clinical research. responsibilities have spanned the full duration of studies, from start-up to project close-out including mentoring to inexperienced cras, monitoring of global/multi-national studies (Phase II & iii) and management of the clinical supplies, as well as interaction with vendors and third parties. (latin america & europe) significant experience in infectious disease, cardiovascular, oncology, parkinson disease. specialties: Clinical trials management, Infectious diseases

Experiences

Current Experience

  • International Clinical Trial Manager


    Since July 2015

Past Experience

  • Project Manager

    September 2014 --- June 2015

  • International Clinical Trial Manager

    October 2012 --- September 2014
    Project Management for a multinational program for Gastroenterology.

  • Clinical Operations Leader

    April 2012 --- August 2012
    global Clinical operations Leader for psoriasis Phase III trial

  • Sr. CRA

    October 2011 --- March 2012
    -full monitor responsibilities. -ec & ca submissions. -alzheimer Phase II

  • Clinical Team Lead

    April 2007 --- May 2010
    responsibilities included coordination and management of study Logistics, of the Clinical monitoring team, site management as well as liaising with the customer and third parties. lead for: Phase III- flu Phase III- chronic heart failure Phase III – advanced parkinson disease (countries involved: argentina, brazil, chile, colombia and peru Phase III- advanced prostate Cancer (countries involved: argentina, brazil and mexico)

  • Sr. Clinical Research Associate

    April 2006 --- April 2007
    - full monitoring responsibilities - mentor junior cras - development of strategies to increase recruitment monitor for: Phase III in advanced prostate Cancer

  • Clinical Research Associate (CRA)

    November 2004 --- April 2006
    - full monitoring responsibilities - collection of high quality critical documents and completion of Ethics committee and regulatory submissions as applicable for study start-up. - management of study supplies/importations - mentoring to junior cras. monitor for: Phase III in pneumonia Phase II in bacteraemia

  • Clinical Research Associate (CRA)

    January 2004 --- November 2004
    site Clinical Monitor - full monitoring responsibilities. - management of study supplies and ip relabeling monitor for: Phase III in hiv Phase III in high risk atherotrombotic patients Phase III in atrial fibrillation

  • Resident Biochemistry

    January 1997 --- January 2001
    Training educational / work experience at the Clinical laboratory

Knowledge

LinkedIn Assessment :
CTMSICH-GCPCROClinical trialsGCPEDCRegulatory submissionsTherapeutic AreasoncologyClinical researchPharmaceutical IndustryCardiologyMedicineInternal medicineDiabetesNeuroscienceNeurologyClinical operationsGastroenterologyMedical writing

Education

  • Specialist in Clinical Biochemistry in Clinical Biochemistry specialized in Microbiology from Instituto Universitario CEMIC in 2001
  • None in Fellowship in Molecular epidemiology and anti-infectives from University of Iowa in 2000
  • Biochemist in Biochemistry from University of Buenos Aires in 1996

Area / Region

Vedbæk, Denmark

Others

Driving License
  • Yes

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