Roman Moiseev

Background

About Roman Moiseev

As a Clinical Lead I am working primarily on large cardiovascular program as a core project team member representing clinical delivery for the customer. I am a Clinical Research Professional with 9 years of extensive International Leadership experience and a high pharmaceutical education. During this time I have demonstrated excellence and strength in clinical monitoring and management during my progression from CRA to Clinical Lead position. As a member of the core project team I am performing partners activities with Project Leadership to ensure overall project meets delivery requirements and I am responsible for the clinical delivery of the study along with Centralized monitoring team, trainings and oversight of the CRAs team, managing the clinical operational aspects of projects to meet contractual requirements in accordance with the protocol, clinical operations plan, applicable SOPs, policies and practices. In have experience in phase II, b studies and in the following therapeutic areas: cardiovascular, oncology, hepatic infection, bronchial asthma, gastroenterology, nephrology, endocrinology, rheumatology, dermatology in pediatric and adult populations. I have participated in several Sponsor’s and Investigator`s Meetings in EU region. I passed sites and electronic Trial Master File audits and inspections. I have created and developed CAPA plans until resolution. I am versed in using complex clinical trial management systems for daily clinical operations: IVRS/IWRS, EDC (data entry), Medidata, Inform, Oracle and other electronic systems.