Site Identification Lead
St Petersburg, Russia
• leading global site identification assessments (post-award feasibility)• leading global strategic feasibility in terms of proposal development and bid defense preparation• protocol review for medical and scientific soundness and revision of it if needed• study design improvement from feasibility point of view• schedule of events revision from medical point of view for budgeting purposes• projecting # of SAEs and SUSARs per study for budgeting purposes• performing protocol-specific training for the project team• investigator grant calculation at pre-award stage (using internal tools and Medidata)• country-level feasibility in Russia, Ukraine, Belarus, Georgia, Israel and Kazakhstan• identification of KOLs and potential sites, maintenance of relationships with them Therapeutic areas of my projects: Hematology, Clotting Disorders, Rare Diseases (including several GMO and gene therapy trials), Oncology, Infectious Diseases (antibiotics and antifungals), Inflammatory Bowel Diseases, Multiple Sclerosis Key achievements at PSI: Leading pre-award strategic feasibility projects - 35 Leading site identification& standalone feasibility projects - 7 Country-level feasibility requests - 464 Investigator grants calculation - 11 Bid defense participation - 2 • I became a department-level expert and primary contact person in strategic feasibility and site identification for clotting disorders, rare diseases and GMO/gene therapy trials. For my last project in rare clotting disorders I had to develop a disease severity classification (due to a lack of international guidelines) and key elements of study design • I played a key role in establishing a new business process – site identification • I improved an investigator grant template and investigator grant calculation process to make it less time-consuming, more efficient and transparent
