Clinical Operations Consultant

2/2002 – 9/2015

Consultant with over 14 years experience in all aspects of clinical development
Over 6 years study/line-management experience
International experience in DE, FR, UK, IE, AT, PL, IT, CH and IL with a wide variety of indications and patient populations
Phase I to IV clinical, observational and non-interventional pharmacoeconomic studies
Protocol development, report and medical writing
EDC requirement specification and data management supervision
Provider selection (specialty labs, IVRS providers, eCRF providers etc.)
CP evaluation and contracts
SOP development for all aspects of operations
EC submissions and regulatory affairs supervision
Audit preparations and co-auditing
Personnel selection (hiring and outsourcing), training and development
Development of study plans, report templates and tools
Managing international teams across regulatory regions
Full responsibility for study delivery
Project and Financial Controlling

Biologie