Dr. Sophie Hytteballe

I am a dedicated, conscientious and result oriented Senior Project Manager with a deep understanding of the clinical processes and the systems supporting these. I have managed clinical projects involving multiple international stakeholders and vendors, while focusing on delivering the optimal technological solution for the customer. As a Project Manager, I focus on high quality and sustainability in implementation of clinical systems. I have extensive experience within Pharma and Medical Device development processes as well as operations ensuring that any system handed over after project closure is truly ready for go-live. My experience includes business case development, digital transformation, process analysis and optimization, validation, change management, quality management and operational management. I have extensive knowledge of CDISC, GAMP5, PRINCEII, CTMS and clinical development processes.