• Building and managing the clinical operations department • Managing functions like Regulatory, Clinical Finance, Data Management, Site Management and Monitoring, Project Management, Vendor Management, Supply Chain • Effectively scaling up the organization • Budget management and oversight (≈ 60M $) • Acting as program director supporting compound development • Creating SOPs, processes, policies, and working instruction • Interacting with investigators, advocacy groups, and regulators (FDA, EMA), • Very close collaboration with CMO, COO and CEO

Lectures about GCP and clinical trials management for Biology, Biotechnology, Medical Technology and postgraduate students • Consultancy in the field of cooperation with business

• Study Management Leadership team core member • Line management to the team covering a global portfolio operationalization • Operational Management across Study Management

leadership and oversight in the delivery of oncology clinical trials in the CEE region (Bosnia, Croatia, Czech Rep., Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, Slovenia) line managing groups of Clinical Study Managers and Clinical Country Specialist • member of the Regional Leadership Team responsible for building a strategy, managing the whole organization, implementing the goals, improving risk management, and effective decision-making

building the Clinical Data Review department, shaping the organization, recruiting, and hiring • leading organizations including setting up and monitoring objectives • line managing a group of Clinical Data Reviewers and Lead Clinical Data Reviewers • transforming, optimizing, and simplifying processes in data review (less manual work, more well-programed edit checks, smart listings) • Led global transformational task forces and initiatives like Optimizing Medical Data Review and transformation of clinical data management into a centralized data review model • vendor liaison for clinical data management and clinical trials management

development of projects execution strategies and studies deployment solutions in a Central and Eastern Europe region • leadership and oversight in the delivery of clinical trials in the CEET region (Czech Rep., Estonia, Georgia, Hungary, Latvia, Lithuania, Moldova, Poland, Romania, Russia, and Turkey) • line managing a group of Clinical Site Managers and Clinical Data Quality Managers • vendor oversight and partnership (CRO, phase I units, SMOs, Functional Service Providers) • building a Clinical Site Monitoring team in Hungary

• execution of clinical trials in Central and Eastern Europe • project management and coordination of clinical trials activities • monitoring budget and study payment • CRO oversight • CTMS global expert and trainer

ICH GCP R3