- Implementation and maintenance of Quality Management System in GxP area- Quality assessment & management of local GxP vendors- Performance of risk based site quality visits- Performance of audit and inspection readiness check visits - Preparation, execution/ facilitation and follow-up of audits/ inspections on clinical development activities- CAPA plan generation and management after audits/ inspections- GxP SOP quality review and approval- Quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assuring that gaps are addressed appropriately in order to mitigate risk - Performance of IMP release - Medical management quality review- Internal GxP self-inspection conduction (PV, Clinical Research, Post Marketing Studies)- Review and implementation of clinical quality management plan- Conduction of management team meetings- Communication with authorities for any GCP/PV related activity after audits/ inspections- Conduction of trainings for GxP related activities as well as support in training activities upon requests from departments

Management of 10 international studies in diabetes (T2DM) - 3, oncology - 2, asthma – 2, osteoporosis – 1, psychiatry - 1, ophthalmology – 1 starting from protocol feasibility.Successfully managed and delivered study results for 10 international studies (all studies – over 180 sites in 14 countries). 3 studies with LPE/LPI "exceeds objective"; 1 study LPI met within shorten timelines; 3 studies with the recruitment > 100%;- Management of clinical team: from 2 up to over 20 CRAs in 1 study. Ensured success by using good leadership skills, organisational skills, regular communication, team motivation and training, operational team meetings, CRA training and investigator meetings. - Effectively coordinated and managed the logistical and general regulatory activities of participating countries to ensure timeframes and targets were met. This included preparation and management of clinical supplies, study materials to be consistent with the program strategy and meet study targets.- Reporting of the studies progress to the senior management.Liaised closely with Data Management to ensure the accuracy of the data in the Database.- Electronic Data Capture: CRA mentoring, supervising. Timely and qualitative data delivery.- Budget management (local level).- Study documents (protocol, guides, CRF etc) review and editing (local level).

Pr. CRA in 2 international phase III studies (2 gastroenterology):- Acted as a trainer and mentor for other CRAs involved in the study in Russia. - Conducted quality assessment and training visits. In conjunction with the CTL, created and adapted the tools and procedures for the study team.- Performed site selection – close-out visits in accordance with contracted scope of work and GCP.This is in addition to the previous responsibilities (senior CRA).

CRA in 3 international phase III studies (2 gastroenterology & oncology):- Responsible for all monitoring activities (study start-up – site close out visits), 11 sites.- Acted as primary contact person to co-ordinate projects in Russia.- Co-ordinated regulatory aspects for Russia to set up the study in accordance with local regulations: accountable for all local regulatory approvals.- Set up and managed logistical arrangements for the distribution of study material, investigational product and collection of laboratory samples and CRFs. - Developed effective working relationships with investigators.- Effectively supervised Clinical Trial Administrators through regular activities, daily contact to resolve site-specific issues.

CRA in 4 international phase III studies (pulmonology, immunology, endocrinology) - Performed full monitoring activities, beginning from study start up (activities on regulatory procedures, logistical arrangements), performing monitoring at sites till the end of studies with close out visits, archiving of project documentation and local arrangements of IP destruction.- Responsible for monitoring of 7-10 sites in each international study with good attention to detail, assured on site data quality and timely transmission of study data to DM.

- Support and assistance of the clinical team in carrying out their start-up, monitoring - close out activities