Experience

MedTransService LLC

• Russian Federation
• Translation and Localization
• 1 - 100 Employee

• Quality and Training Manager in Translation Agency MedTransService

  • Aug 2015 - Present

  - Quality Management and Quality Control activities including SOP management, support, consultancy, coaching and training to company staff, preparation for customer audits; - External services: clinical quality consultancy and support to CROs and pharmaceutical companies in preparation for customer audits and regulatory inspections; development and delivery of different trainings on different aspects of Clinical Research and personal development trainings including both classroom, virtual and on-job trainings. Show less



Quintiles GsmbH

• St.Petersburg (Russia)

• Global Learning Training Manager

  • Feb 2010 - Aug 2015

  2010-2015 – Global Learning Training Manager in Europe and Middle East, and 2011-2013 - Global Curriculum Manager L&D in Quintiles GsmbH. Responsibilities: - leading strategy, design and development of all role-based curriculum and developed training plans for specific roles; - design and delivery of different types of clinical and soft-skills personal development trainings (both face-to-face and virtual) to clinical staff (CRAs, Project Managers, Quality Managers) and to the non-clinical company staff in Europe, Asia and Middle East, and to clinical Investigators; - facilitation of all types of company department and Investigators meetings and conferences; - performance consulting to different Business units and departments both clinical and non-clinical; - Quality Management and Quality Control activities and support to clinical monitors, Project Managers, quality managers, start-up groups; - support, consultancy and assistance in preparation for customer audits and regulatory inspections (including FDA and EMEA). Show less



Quintiles GesmbH

• Clinical Research Training Manager Europe in Quintiles GsmbH (freelancer contract)

  • 2000 - 2010

  2000-2010 – Clinical Research Training Manager in Europe and Middle East in Quintiles GsmbH. Responsibilities: - development of training plans for clinical staff; - design and delivery of all types of clinical trainings in Clinical Research, ICH GCP, GMP, EU Directive, etc., including ICH GCP and project specific trainings to clinical Investigators;- development and conduct of seminars and the delivery of presentations on different aspects of Clinical Research including monitoring activities and Quality management to CRAs, assistants, Project Managers, etc.; - conduct of the accompanied on-job quality visits with CRAs to investigational sites;- Quality Management activities including support and assistance for monitors and investigators in preparation for dozens of audits and regulatory inspections (including FDA and EMEA);- Member of Global Clinical SOP Management team. Show less

• Clinical Research Trainer (freelancer contract)

  • 2005 - 2009

  From 2005 till 2009 I was working as a Clinical Research Trainer (freelancer contract).Responsibilities:- Delivery of clinical and soft-skills training, facilitation of conferences and meetings, and consulting services to other CROs and Pharma companies (Parexel, Cromos, ExQuisite Alliance, Clinstar Europe, CRA Club, Pharmaquest Jo (Jordan); Pharm-Syntez,), Vienna School of Clinical (Austria).

• Clinical Research Associate (CRA)

  • May 1998 - 2000

  1998-2000 – Clinical Research Associate (CRA) in Quintiles GsmbH company (CRO) Responsibilities:- all types of monitoring activities - site monitoring visits, pre-visit and post-visit follow-up, Investigators meetings;- support to the investigational sites in preparation for customer audits, attendance at FDA regulatory inspection.



SanaClis (storage depo)

• Kiev Region, Ukraine

• Quality Manager in the Facility for IMP and Clinical Trial Supplies (freelancer contract)

  • 2003 - 2006

  2003-2006 – Quality Manager in the Facility for IMP and Clinical Trial Supplies SanaClis (storage depo) in Kiev, Ukraine (freelancer contract). Responsibilities: - Quality Management and Quality Control activities: managing SOPs, providing support, consultancy, coaching and training to company staff, preparation for customer audits and regulatory inspections (including FDA). 2003-2006 – Quality Manager in the Facility for IMP and Clinical Trial Supplies SanaClis (storage depo) in Kiev, Ukraine (freelancer contract). Responsibilities: - Quality Management and Quality Control activities: managing SOPs, providing support, consultancy, coaching and training to company staff, preparation for customer audits and regulatory inspections (including FDA).



Medical College Nr 1 in St.Petersburg

• St.Petersburg (Russia)

• Teacher of Nursing Practice in English

  • Sep 1993 - May 1998



Economical College, St.Petersburg

• St.Petersburg (Russia)

• Teacher of English Language

  • Aug 1989 - Nov 1992



Military Hospital of War Invalids in St.Petersburg

• St.Petersburg (Russia)

• General nurse

  • Aug 1988 - Aug 1990

  Working in cardio department intensive care unit as a general nurse Working in cardio department intensive care unit as a general nurse