Malgorzata Neumann

Background

About Malgorzata Neumann

Strong research background with more than 17 years of progressive experience in the Clinical Research industry. Experience background includes roles as Clinical Operations Leader, Resource Manager, Site Visit Report Reviewer, Clinical Research Associate, in a wide range of therapeutic indications on global, multi-center studies from start-up, recruitment and maintenance phase to closure. Experience in preparations and follow up for internal/external audits, inspections on phase II and phase study. Clinical trials management experience on the COL role including Global masked COL role in large ophthalmology study, Global Unmasked COL role in large hematology studies and management of a large infectious disease and ophthalmology studies as Regional COL. Extensive monitoring experience from start-up to closure, including coordination and performing clinical on-site monitoring activities, collecting regulatory documentation, performing feasibility, qualification, initiation, monitoring and termination of investigational sites. Strong communication and leadership skills, leading study team, effectively communicating with internal and external customers as well as third party vendors. Strong organizational and time management skills proofed with taking additional tasks:(2 years) as a Resource Manager for Site Visit Report Reviewers global team (covering over one hundred of head counts and several hundreds of studies) and some quality related activities - inspection readiness activities working at Sponsor office in UK, quality check of approved reports for CE/EE/MENA/SSA team and new team members mentoring and onboarding