Clinical Study Oversight (Oncology, Russia) Led the coordination and oversight of clinical studies in onco-urology and hematology in Russia, managing all phases from planning and site initiation to monitoring and close-out. Ensured alignment with global timelines and regulatory standards. CRA Team Leadership Supervised teams of CRAs and Sr. CRAs, assigning responsibilities, monitoring progress, and ensuring adherence to study protocols and GCP guidelines. Regulatory Documentation Management Contributed to the development and localization of regulatory documents, including Informed Consent Forms (ICFs) and cover letters, for submission to Ethics Committees (IRB/LEC). Stakeholder Communication Maintained effective cross-functional communication with global and local teams, vendors, investigational sites, and regulatory authorities to ensure smooth study execution. Quality and Timelines Control Oversaw timely submission of essential documents and managed logistics workflows, including tracking of document flow and shipment status. Audit and Inspection Readiness Prepared teams and documentation for internal and external audits and inspections, ensuring compliance with regulatory and sponsor requirements. Training and Mentorship Facilitated onboarding and training of new team members, promoted knowledge sharing, and supported continuous professional development within the team. System and Tracker Management Maintained and updated study trackers (e.g., Study Document Tracker), ensured accurate data entry in corporate systems, and worked with platforms such as SharePoint and Veeva Vault.

Local Phase IV Study (Virology, Russia) Served as Clinical Study Manager (CSM) for a large-scale local Phase IV study involving over 60 sites and 1,500+ subjects across Russia. Oversaw full study lifecycle: site selection, initiation, monitoring, and close-out. Achieved enrollment of 1,500+ subjects across 55 active sites. Established and led regular Steering Committee meetings to align stakeholders and drive study progress. Global Phase II Studies (Oncology, Russia, Georgia, Kazakhstan) Managed two global Phase II oncology studies, each with 4 sites and approximately 30 subjects. Coordinated study activities in alignment with global timelines and quality standards. Ensured seamless collaboration with global teams and vendors. Team Leadership & Vendor Collaboration Line management of 4 internal CRAs and 5 external CRAs, including performance reviews, coaching, and annual assessments. Mentored and supported professional development of 2 CRAs and 2 CTAs. Collaborated with external vendors including Synergy (data management), Quintiles and RusBioNT (monitoring). Led contract negotiations with sites and investigators, managed study budgets, and ensured timely payments. Cross-Functional Coordination Actively participated in regular Study Management Team (SMT) meetings. Maintained oversight of operational deliverables, timelines, and compliance with regulatory requirements.

Local Phase IV Oncology Studies Oversaw two Phase IV oncology studies as sCRA, managing two external CRAs from a local CRO. Conducted regular co-monitoring visits and supervised CRO activities related to data management and query resolution. Successfully supported both studies through database lock and Clinical Study Report (CSR) finalization. International Phase III Oncology Studies Responsible for full-site management across three global Phase III oncology studies (15 sites total). Key responsibilities included site feasibility assessments, regulatory submissions, site initiation, routine monitoring, and close-out activities. Delivered on-time execution of: Site feasibility, regulatory submissions, and site initiations Ongoing monitoring of 6 active sites Final monitoring visits, query resolution, and site close-out

Managed two international Phase III oncology studies in Russia, each involving 6 investigational sites. Responsible for full-site management lifecycle: site feasibility, initiation, routine monitoring, and close-out visits. Ensured compliance with study protocols, GCP, and regulatory requirements throughout all trial phases. Successfully adhered to tight timelines, contributing to on-schedule database lock for both studies.

Managed 9 investigational sites in Russia as part of a global Phase III oncology study. Responsible for comprehensive site management, including, contract negotiations with sites and investigators, site initiation, routine monitoring, and close-out activities. Ensured compliance with regulatory requirements and study timelines, contributing to the successful execution of the study.

Feb 2008 – Sep 2008 Managed 5 investigational sites across Russia and Belarus in a global Phase III urology study, also conducted in the EU. Responsibilities included submissions to Ethics Committees and regulatory authorities, contract negotiations with sites and investigators, site initiation, monitoring, and close-out. Delivered on-site training for new CRAs and participated in both start-up and final Investigator/CRA meetings. May 2007 – Mar 2008 Oversaw 5 sites in Russia for a global Phase II urology study, also conducted in the EU. Successfully enrolled 60 patients within a two-week enrollment window. Managed regulatory submissions, contract negotiations, site initiation, monitoring, and close-out. Participated in start-up and final Investigator/CRA meetings. May 2006 – Nov 2007 Responsible for 6 sites in Russia in a global Phase IIIb/IV urology study, also conducted in the EU. Handled regulatory and EC submissions, site initiation, monitoring, and close-out activities.