Consultant Clinical Research, CRA, PM, start-up, regulatory

M. B. has 12 years experience in clinical research as a university research associate, CRO field monitor, clinical team leader in oncology/hematology and infectious diseases trials as well as a study documenter across Phase I to Phase IV

• Drug Discovery12 J.
• Medizin
• Medizinforschung
• Naturwissenschaft
• Pharmazie
• UNCLASSIFIED

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Business development
• RfP analysis and proposal writing
• Market assessments
• Bid defense presentations EU/US, pitch rehearsal
Health economics
• Health care systems, health economic evaluations
• Clinical trial costs
Operations and regulatory management
• Site visits, clinical troubleshooting and auditing
• Managing sponsor and client contacts
• Project management and delivery
• Executive summaries and progress reports
• Start-up and contract management, submissions to regulatory agencies and EC/IRBs, feasibilities
• Experience in > 100 phase I-IV trials: Oncology, hematology, rheumatology, immunology, hepatology, pulmonology, cardiology, CNS, infectious diseases, vaccines, GI, pediatric trials, nephrology, endocrinology, dermatology, non-interventional trials, late phase, NIS, controlled substances, medical devices, orphan drugs, ATMPs, transplantation-, virus-and cell-therapy trials
Counseling
• Lecturer in seminars and courses, academic counseling, adult education
• CRA training, mentoring and line management