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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