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Experiences

Current Experience

  • Sr. Global Clinical Oerations Leader
    Since May 2011

Past Experience

  • Sr. Global Clinical Operations Leader
    March 1999 --- February 2017

    22 years’ experience in Clinical Research throughout phase II – Phase IV studies, 11 years as Global Clinical Operation Leader leading large team across the globe from study planning, start-up, through project life cycle until the completion of Clinical Study Report - solid knowledge and in- depth understanding of clinical trial process and drug development- knowledgeable in ICH-GCP and other applicable local regulations - Significant Experience in managing large-scale studies and/or programs, responsible for the strategy and execution of complicated global drug development programs.

    • FDA inspection in 2004 on Cardiovascular phase III trial conducted in Norway – Responsible area: Field CRA.
    •  FDA inspection in 2014 on Anti-emesis drug in oncology patients, phase II-III trials. The inspection was conducted in India, Hungary and Poland – Responsible area: Program Global Clinical Operation Leader accountable for the team deliverables and the study data quality.

    THERAPEUTIC AREA EXPERTISE: • Oncology (Anti-emesis, lymphoma) • Cardiovascular (Hypertension, Myocardial Infarction, Congestive Heart Failure, Coronary Artery Disease, Cardiovascular Disease, Arteriosclerosis, Unstable Angina) • Endocrine/Metabolism (Acromegaly, Diabetes, Hypercholesterolemia, Obesity, Thyroid Disorder) • Neurology (Stroke, Multiple Sclerosis, Insomnia) • Obstetrics/Gynecology (Infertility, Menopause, Osteoporosis) • Dermatology (Psoriasis) • Hematology (Anemia)

  • Global Clinical Lead
    June 2007 --- April 2011

  • Co- Clinical Lead/ Lead CRA
    July 2006 --- May 2007

  • Senior Clinical Research Associate (CRA)
    August 1998 --- May 2006

  • Clinical Research Coordinator
    January 1994 --- July 1998

Education

  • Bachelor in Pharmacy from Oslo College in 1993

Training and Certification

  • Heart & Brain Symposium in Istanbul in 2001 Training
  • The American Society for Bone and Mineral Research and the International Bone and Mineral Society, 2nd Joint Meeting in Sanfrancisco in 1998 Training
  • Consensus Conference on Osteoporosis in 1996 Training
  • Dexa-scan operator course in Copenhagen in 1996 Training
  • Osteoporosis World Congress, Amsterdam in 1996 Training
  • CRA Certification in 2002 Certification
  • English Business Course in 2000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
VIETNAMESE
Native
Norwegian
Native
English
Full Proficiency
Swedish
Full Proficiency
Danish
Professional Proficiency
Italian
Elementary Proficiency

Area / Region

Oslo, Norway

Others

Driving License
  • Yes