Head of Clinical Study Management Team with over 15-years of experience within the clinical research industry.
Extensive scientific experience in planning of pre-clinical-, bioequivalence-, phase III and IV – studies design. Experienced project leader in preclinical and clinical studies execution. Supervisor of GCP compliant system, author of SOPs and auditor of vendors.
Leading a group of clinical specialist responsible for studies execution according to EMA/TPF/FDA regulations and GCP/GMP requirements.