Jan Kresta

Background

About Jan Kresta

I have been working in a clinical trial research since 2005, holding a Master of Sciences of Pharmacy degree. I started to work as a Clinical Research Associate supporting big pharmaceutical companies / leaders in a drug research (2005-2014). In 2011-2014 I also coordinated as a Project Manager in a large local project with DM2 patients. In 2014-2015 I worked on a position of Site Relation Manager supporting subject recruitment at 10 sites in the Czech Rep. and at 24 sites in Poland within Phase 3 study for a treatment of endometriosis. In 2015-2022 I worked as Study Management Associate (SMA) which is a position within a Project Management ("right hand" of the Study Project Manager). This position coordinates activities in clinical studies in accordance with the protocol(s) and ICH-GCP. SMA works with many cross-functional team (incl. CRO) to ensure the initiation, conduct and completion of the clinical study are done and the study goals are met. Lead study activities such as protocol and informed consent preparation, investigator meeting, vendor selection and oversight and monitoring activities oversight Identify issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues. From Mar-2023 to Oct-2023 I was working as a global Clinical Trial Lead in CRO managing monitoring/start-up team in 15 countries in Phase oncology study. The project was stopped due Sponsor decision. Since Nov-2023 I have been working as a global Clinical Project Lead for another CRO having the responsibility for about 20 countries in EMEA/APAC regions.