30 years of experience with the pharmaceutical Industry, as CRA, Study Manager, Start-Up Specialist and Contract Specialist. The work has been both in the pharmaceutical industry, GCP-Unit as well as in Contract Research Organizations.
I am experienced in feasibility/validation, start-up/Initiation, site management (CRF completion, query resolution, drug accountability, patient questionnaires, meetings) as well as close-out procedures. Used to working with several studies at the same time and cross border. I have made submission to authorities and negotiated contracts and budgets.
Experience in phase I-IV studies in a variety of therapeutic areas (lung, hearth, infectious, rheumatoid arthritis, oncology, hematology etc).
Furthermore, I have worked as Clinical Research Manager on several projects within the areas of Oncology.
I am flexible, service-minded, pro-active and find it important to ensure strong communication and close contact with all related teams, as well as with all internal departments and clients.
Danish native speaking, other Nordic languages are understood in communication and writing, fluent English spoken and written.
Mentoring and training of CRA colleagues. Investigator’s meeting. Quality Visits. Clinical Oversight and Management Tasks