BrightOwl Loader Loading

Summary

Holds a first medical degree in Traumatology and Orthopedics in Russian State Medical Academy, Voronezh. Also passed successfully internship and postgraduate education in Clinical Pharmacology, Pharmacotherapy and urgent medical care. The result of these 5 years of postgraduate education was defending of a thesis (PhD). Clinical Research professional with 10 years experience managing international and local clinical trials both for medical drugs and for medical devices. Very inquisitive and creative. Proven communication and leadership skills, effective team builder who drives and motivates teams to success. Excellent understanding of cultural differences with abil-ity to influence internal and external clients. Comprehensive knowledge of clinical research regula-tions and practices in Russian Federation, CIS and European countries. Successfully supervise and manage all aspects of cardiovascular, pulmonary, orthopedic, rheumatolo-gy, oncology, gastroenterology and other trials.

Experiences

Current Experience

  • Global Clinical Project Manager (GCPM, GTM)
    Since August 2015

Past Experience

  • Chief Operating Officer, Russia/CIS
    May 2014 --- August 2015
    - Direct and define the scope of work, objectives, quality of deliverables, and other project and study management activities. - Serve as primary project contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to. - Ensure the development and implementation of project plans for all phases of the project lifecycle, including the quality and risk management, ensuring that issue escalation and resolution is clear. - To prepare and finalize the project budgets and scope of work and manage project budgets to meet financial and company goals, proactively ensuring adherence to change control processes. - Direct and define project and study management activities for team members related to their project-oriented tasks to ensure that project/program milestones are met. - Continually review and ensure adequate resources are available to meet deliverables and milestones. - Develop, lead and implement continuous improvement for assigned projects and programs. - Act as the key relationship manager for assigned clients; recommend courses of action regarding client management issues; gain approval and support from senior management across the organization for plan. - Accountable for the financial oversight and goals for project/program, to meet company realization targets. - Provide consultation to clients on drug development process, study management strategy, and plans as needed. - Lead proposal and budget development activities, evaluate feasibility of potential programs and impact on company operations and goals, negotiate and make decisions on behalf of the organization. Participate in sales/proposal presentations in face-to-face meetings with potential clients. - Influence and shape the direction of Clinical Project Management, including recommendations regarding policies and practices. - Participate in function and/or corporate initiatives, special project assignments, and as a client liaison

  • Chief Project Manager (CPM) for Russia/CIS
    January 2014 --- August 2015
    - Control functions: Supervise all ongoing projects: Supervise and rectify performance of subordinate department managers (CR, DM and Stat.); analyze information of QA internal audits and external audits and undertake appropriate corrective measures; - Manpower: take decisions on employment of new staff members; designate manag-ers of subordinate departments; - Other: coordinate work of all departments; take decisions on any changes in internal structure (departments, affiliates); organize work on website, editing of website con-tent; - Internal trainings: prepare presentations; deliver lectures; conduct practical sessions; - GCP trainings and seminars (basic and advanced): prepare presentations; deliver lec-tures; conduct practical sessions; counsel medical departments staff on different ques-tions arising in connection with ongoing projects; - Documents: participate in development of and approve internal standard operating procedures; participate in development, writing and approve protocols, CRFs and oth-er documents; check final study reports. - Heading project team: approval of the translations of the study-related documents (protocols, ICFs, etc.); distribute responsibilities between subordinate project team members; coordinate work of subordinate project team members; supervise and rectify performance of subordinate project team members; manage regulatory affairs (commu-nication with regulatory authorities, obtaining required approvals, etc.); ensure compli-ance of subordinate staff with applicable SOPs (sponsor and/or AmeRuss); organize and perform Study Specific Trainings for monitors; perform co-monitoring visits; organize regular project team meetings for discussion of the ongoing project; organize start-up and other investigator’s meetings (logistics); manage the Study status and monitoring activities; resolve project-related problems that cannot be resolved on the level of de-partment managers;

  • Senior Project Manager (PM)
    October 2010 --- August 2015
    - Relations with customers: negotiate with customers; prepare budgets proposals for customers; perform other marketing and advertising activities; contract negotiation with 3rd parties/subcontractors. - Control functions: Supervise ongoing projects: Supervise and rectify performance of subordinate department managers (CR, DM and Stat.); analyze information of QA internal audits and external audits and undertake appropriate corrective measures; Supervise of study budgets and timelines to ensure a performance of tasks according to the project contract. Management of the entire study process in compliance with ICH-GCP, the company SOPs, as well as national and international regulations. Co-operation with the Central Ethics Committee and to the Regulatory Authorities. Co-monitoring of investigator sites. Co-management of patient recruitment strategies. Management of investigator meetings. - Manpower: take decisions on employment of new staff members (of subordinate departments: CR, DM and Stat.); designate managers of subordinate departments; - General control: coordinate work of all departments; take decisions on any changes in internal structure; organize work on website, editing of website content; - Internal trainings: prepare presentations; deliver lectures; conduct practical sessions; counsel medical department’s staff on different questions arising in connection with ongoing projects; - Documents: Participate in review and development of SOPs, forms, instructions, templates and other internal documentation; participate in development, writing and approve protocols, ICDs, CRFs and other documents; check integrated study reports.

  • SrCRA/CTL
    December 2009 --- October 2010

  • CRA3/CTL
    May 2007 --- January 2010

  • Clinical Research Associate (CRA)
    December 2005 --- May 2007

Knowledge

LinkedIn Assessment :
Clinical trialsoncologyClinical researchClinical pharmacologyCROClinical monitoringICH-GCPCTMSGCPPulmonologyMedical DevicesProject BiddingHiring EmployeesBusiness DevelopmentRegulatory submissionsRegulatory affairsSOPEDCClinical DevelopmentClinical operationsPatient recruitmentDrug DevelopmentClinical Data ManagementPharmacovigilanceMedical affairsRheumatologyVaccinesPharmaceutical IndustryMedical writingTrial ManagementSOP

Education

  • Doctor of Philosophy (Ph.D.) in Post-graduate study from Московский Государственный Медико-Стоматологический Университет (МГМСУ) in 2011
  • Clinical Pharmacologist in Clinical Pharmacology and Pharmacotherapy from Moscow State University of Medicine and Dentistry in 2008
  • MD in Surgery/Traumatology from Voronezh State Medical Academy named after N.N. Burdenko in 2005

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency

Area / Region

Paris, France

Others

Driving License
  • Yes