Sr. Global Clinical Oerations Leader
Since May 2011
Sr. Global Clinical Operations LeaderMarch 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 LeadJune 2007 --- April 2011
Co- Clinical Lead/ Lead CRAJuly 2006 --- May 2007
Senior Clinical Research Associate (CRA)August 1998 --- May 2006
Clinical Research CoordinatorJanuary 1994 --- July 1998
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