Basel, Basel, Switzerland
I am a highly experienced and accomplished Global Clinical Study Manager, with a degree in Biology with extensive clinical research experience in hematology, oncology, neurology and cardiology within the pharmaceutical industry. In depth knowledge in ICH/GCP and regulatory requirements, therapeutic knowledge in solid tumor indications, Multiple Sclerosis, Migraine and rare diseases like Paroxysmal Nocturnal Hemoglobinuria (PNH), Hemophilia and Pulmonary Arterial Hypertension. Global management of all aspects of international clinical trials from phase I- IV according to local regulations and SOPs.
• Approval and management of site related start-up activities of 120 sites in 14 countries (EU and US) in Phase III Migraine trial with anti CGRP Mab (fremanezumab) • Review and approval of study related documents, presentations and training material • Review and approval of study and site budgets • Management of CRO and Vendors (Lab, ECG, EDC etc.) • Review and clarification of content queries from Ethics Committees and Health Authorities
Regional management of phase II trial in Multiple Sclerosis and phase III registration trials in Migraine which involved: Country/site selection, collaboration with and oversight of CRO, maintenance of professional relationship to sites, review of CQA audit reports, liaison for Medical Affairs, review and revision policies and SOPs.
• Operational management of international clinical trials in oncology, Phase II, III and-IV in Austria, Switzerland and Germany in Cancer of the Breast, Lung (NSCLC), Urothelium and Head & Neck incl. registration trials • Feasibility survey, Sites selection and recruitment of investigators / opinion leaders, incl. negotiation of study budgets, review of contracts and site payments • Collaboration with vendors (IWRS, eCRF, Imaging) • Support of GCP Inspection by Austrian Health Authority AGES/BASG
• Complete submission of clinical research projects to Ethics Committees and Regulatory Authorities in compliance with applicable regulations and guidelines (EC, Non-EC) • Operational management of international clinical trials in oncology, Phase I, II and III in Austria, Switzerland • Initiation of clinical trial sites, training of sites’ staff, assistance and participation in investigator meetings
Support in the operational management of international clinical trials in oncology, Phase II and III in Austria, Switzerland Performance of Site initiation, on site monitoring and close out visits
Implementation of an automated workstation for miniaturised fermenation in natural products screening