Silvia Sommer

Leading outsourcing activities for clinical trials in Immuno-Oncology and other therapeutic areas Vendor evaluation, selection and partnership management Internal and external stakeholder engagement towards successful trial execution Leading and influencing vendor decision making cross-functionally and hierarchically Providing expertise to the Digital trials‘ companywide initiative and leading one of the work streams Project and change management Due diligence & Process enhancements

• Project management for SaaS(Software as a Service) used in clinical development • Resource, risk, time, and budget management • Business case development and evaluation • Stakeholders’ management and team leadership • Motivating and coaching project teams to successful completion of projects • CFR 21 Part 11 requirements for electronic signature and data transfer. • Vendor evaluation and management • System implementation , validation and data migration activities

Project planning, coordination, monitoring, and reporting for laboratory software, medical devices, and patients and caregivers’ web portal. Resource, risk, time, and budget management Business case development and evaluation. Managing and influencing internal stakeholders and external vendors. Monitoring and evaluating deliverables. Creating and updating project documentation. Incorporating the subproject deliverables into the bigger project on time and best quality

International Management