Strategically planning portfolio of new drugs and nutritional supplements for registration and coordinate conducting clinical trials for them. Communication with Key Opinion Leaders and external scientific consultants. Coordinating selection of the Service Vendors (CRO) engaged in the trials, assess and control their work. Control on medical part protocol development.

Strategically planning portfolio of new drugs and nutritional supplements Market access and Registration for new drug and nutritional supplements

ACHIEVEMENTS To manage the operational and business functions of the clinical trials activities in Russia; the Baltic, Ukraine, Europe. Leadership role in EU Operations meeting and management of cross-functional international team (Russia; the Baltic, Ukraine, Europe.) Lead operations according to company SOPs, GCP and countries legislation: HR, sponsor’s audits were passed successfully. Set up company presence in Russia, Baltic States, Ukraine and Europe (at investigative sites) Established vendor collaboration in Russia, Baltic States, Ukraine (sponsors, CROs, Sites, KOL, IT providers, hospitals, MOH, Regulatory Authorities, ECs). Set up Advisory Board from KOL in Russia; the Baltic, Ukraine. RESPONSIBILITES -Responsible for the overall operations of MedAvante’s clinical trials activities in Russia, the Baltic, Ukraine, Europe; ensuring compliance with all applicable legislation. -Responsible for ensuring MedAvante meets its contractual obligations to its clients and that client expectations are met or exceeded during the lifespan of each project. -Plan, direct and coordinate activities and cross-functional projects to ensure that goals and objectives are accomplished within prescribed time frames, budget and quality. Provide input to the Revenue Recognition forecast. ---Working with different CTMS to control budget, timeliness and quality of assigned projects. -Plan and carry out programs for the recruitment, screening, enrollment, and retention of clinical subjects and/or volunteers. May be required to conduct site visits as per client or project demands. -Responsible for ensuring there is adequate coverage and support for project activities. Identify changes in scope and liaise with Project Leader. Participate in client, investigator and team meetings. -Provide reports regarding the status of projects to appropriate personnel on a timely basis. -Provide performance feedback on team members as appropriate.

ACHIEVEMENTS * Started up Regulatory Affairs department and East European Site ID & Feasibilities department in Russia; * Set phase II-IV full monitoring process since sites selection till sites closure-out; * International project management; * Client's collaborations: the preparation of quotations and study proposals for Phase II/III studies and to ensure that enquiries from clients receive a prompt and satisfactory response; * Established vendor collaboration: warehouse, custom clearance for study supplies and medical devices (import, export). * Established from zero and managed the work of the representation Office in Moscow for 4 years; RESPONSIBILITES * To manage the operational and business functions for the clinical trials activities in Russia; * To prepare and agree budgets and financial targets and be responsible for the financial control of activities according to agreed objectives; * To co-ordinate and monitor working hours of other staff and consultants as directed; * Business Development : sales presentation; preparation of quotations and study proposals for Phase II/III studies and to ensure that enquiries from clients receive a prompt and satisfactory response; * To ensure standard contracts meet regional legal requirements and input accordingly to the contract process; * To be responsible for the recruitment and allocation of staff and consultants as agreed, and to ensure that the selection of staff is carried out in accordance with the Company's current agreed standards and techniques.

Moris Torez Institute of Foreign Languages, English/German

General Medicine, Clinical pharmacology, Medical doctor MD.PhD, Cardiologist, Clinical pharmacologist

The Open University., People management. Leadership. Team building. Assertiveness & Conflict resolution. Performance appraisal and feedback.

Kendle, Project management .

Lechivo, Applied Informatic