Global Clinical Project Manager
Since March 2001
Global Clinical Project Manager (Oncology - ELUXA, Diabetes - CAROLINA trial, COPD, Virology (hepatitis), Cardiovascular (VTE) - ONTARGET) Major responsibilities/tasks/experiences/skills: Management of complex and intensive clinical trials, e.g. global cardiovascular outcome trials (6000 to 30.000 patients, > 4 years with budget over 350 million Euro). International Lead of core Clinical Operations teams, contributed to the design and execution of global clinical trials in metabolic, cardiovascular, respiratory and virology therapeutic areas. Leading cross functional teams and responsible for oversight of collaborations with vendors and research organisations. Expert in Project Management. Advanced knowledge of GCP, ICH & FDA guidelines, communication skills, problem solving and intercultural differences. Member of Medical Sub Team to advise and make proposals on trial designs, the overall planning and priority setting of clinical trials. Identification of academic networks and Key External Experts to set-up Academic Steering/Advisory/Data Monitoring/Adjudication Committees to provide input on trial design, trial conduct, study safety, endpoints, abstracts, manuscript development, etc. Member of Executive Steering Committee or Scientific Advisory Committee. Sponsor representative of Data Monitoring Committee. Member of international workgroups. Review of draft protocols, abstracts, publications. Development of clinical trial website. Development and review of SOPs. Training and coaching of colleagues within Clinical Operations. Co-author of abstracts and manuscripts (see below publication list).
Clinical Research Scientist
July 1995 --- February 2001
Clinical Research Associate (CRA)
January 1992 --- June 1995
M. Sc, in Medical Biology from VU University Amsterdam in 1991