Experience

Synergy CRO

• Russian Federation
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Account Management

  • Sep 2016 - Present



global CRO

• Moscow, NY

• chief executive officer

  • Oct 2011 - Aug 2016

  Business development: sales and marketing of CRO services. Executive and direct search in finding Clinical research projects (International Multicentre Clinical Research & Clinical research for Registration in Russia & USA) for Pharmaceutical companies within Russia and USA to provide all CRO` services and outsource of personnel (Clinical Research Associates, Clinical Trial Assistant, Regulatory and Study Startup Specialists, Medical writers) Planning and implementation of marketing strategies. Participation in a tenders. More than 30% were successful. Pricing management. Budget allocation, negotiation and management. Portfolio management. Clinical Operation Leadership and Development Team management of PM and CRAs. Audits of Investigator sites monitoring in compliance with SOPs, ICH/GCP and local laws so site performance targets are achieved and the company’s image with its external customers are enhanced. Driving quality standards by acting as a mentor and providing support to less-experienced colleagues. Local SOP development. Show less



local CRO

• Moscow

• project manager, line manager Russia

  • May 2010 - Nov 2011

  External PM for Novartis: project team management, budget tracking, 15 sites, eCRF. Line manager for local CRO: staff management: recruiting, training, co-monitoring, project teams organization. External PM for Novartis: project team management, budget tracking, 15 sites, eCRF. Line manager for local CRO: staff management: recruiting, training, co-monitoring, project teams organization.



Synergy CRO

• Russian Federation
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head of regional office, clinical research associate, line manager, project manager

  • Aug 2006 - May 2010

  Team management: - motivation strategy developing - coaching - co-monitoring - regular assessment - team building meetings organization Clinical research management:  Feasibility, study start-up, MoH submission, site contract negotiation, preparation of core and Informed Consent Forms; Site evaluation (Pre-study visits), Initiation, routine monitoring and Close-out; Monitoring tools creation; Internal training presentations;  Monitoring the progress of clinical studies at investigative sites (I-IV phase studies).  Ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP and all applicable regulatory requirements Site-staff trainings. Site selection and 34 feasibility process. Close-out site visits. Cooperation with start-up unit in order to select the best sites for a specific study.  Close collaboration with PV department. Ensuring Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary; Verification of subject safety and site adherence to ICH/GCP Guidelines; Adverse event evaluation. Query resolution management during course of the trial as well as before database freeze.  Document management (ISF, SSF, TMF). Creating of a local version of Informed Consent Documents, CRF. Ensuring complete and thorough study drug reconciliation; Visit reports, letters, query resolution and expenses management.  The areas of expertise include Medical Affairs, Clinical Research, Regulatory Affairs, Pharmacovigilance, CRO Staff Outsourcing, Business development Show less



Russian Military Medical Academy

• St-Petersburg, Russia

• operating lazer surgeon - ophtalmologist

  • Aug 2001 - Nov 2008

  Operating lazer surgeon - ophtalmologist and there is two years experience of acting head of lazer surgery ophtalmology department. Surgical treatment (glaucoma, diabetes mellitus, secondary cataract). Teaching load. First experience in Clinical trials as Sub-investigator of two studies, II phase. Since august 2006 I combined this work with homebased position external CRA for Servier. Operating lazer surgeon - ophtalmologist and there is two years experience of acting head of lazer surgery ophtalmology department. Surgical treatment (glaucoma, diabetes mellitus, secondary cataract). Teaching load. First experience in Clinical trials as Sub-investigator of two studies, II phase. Since august 2006 I combined this work with homebased position external CRA for Servier.