Sylvia Schwarz

Senior Consultant, GxPAssure

Sylvia Schwarz has more than 19 years experience in mostly Clinical Operations focused roles in larger pharmaceutical and smaller biotech companies. Sylvia’s special focus is on operational and process management. 

Sylvia has experience in :

• Clinical Development expertise with innovative compounds and biosimilars, small molecules, biologicals and vaccines
• Indication experience: Oncology, Inflammatory Diseases and prevention of Infectious Diseases
• Experience in planning, set-up, conduct and reporting of global Phase I – III including First-in-Human and Healthy Volunteer trials
• Development and improvement of processes, Standard Operating Procedures, Guidance documents and systems in Clinical Development, also based on inspection findings from external and internal assessment
• Set-up and adaptation of clinical part of Quality Management System to be phase I- and II-ready
• 19 years of experience in vendor/third-party selection, set-up, management and oversight. Participation as SME in vendor audits including CAPA management and follow-up
• Development and implementation of Collaboration Manual with preferred provider Clinical Research Organization
• Systems: electronic Trial Master File, Interactive Response Technology, electronic Diary/electronic Clinical Outcome Assessment, electronic Data Capture. Leader of task force to select electronic Trial Master File provider