Main responsibilities: CSS: all aspects of clinical trials management activities from study feasibility to study closure under supervision of regional CSM, regional CSM back – up and support in vendors/CRAs/Sites interaction and communication (Insourced Studies). CSM functions: studies conduct supervision/budget review as primary Sponsor affiliate contact (Outsourced Studies). Additional responsibilities: Feasibility/Landscaping activity for the region (Russia, Balkans, Ukraine, Belarus, Georgia, Kazakhstan). eTMF review responsibility for PD studies. Responsible therapeutic areas/CT Phases: Rheumatology, Hematology (oncology), Hematology (Hemophilia), Oncology, Inflammatory.

Clinical Research Associate Main responsibilities: All aspects of clinical trials monitoring activities from study start-up to study close - out (sites feasibility, initiation, management, regulatory and EC affaires, audit and inspections preparation, study closeout). Additional responsibilities: Study documentation reviewer for Eastern Europe and Russia region – site level. Responsible therapeutic areas/CT Phases: Psychiatry (Phase III Study), Neurology (Phase III Study), Endocrinology (Phase III Study). Non – Interventional study experience.

Main responsibilities: GxP, SOPs, QA trainings for investigators and monitors, GxP, SOPs, QA trainings programs development. Clinical Trials consulting (QA, risk management). Additional responsibilities: business development activities, contracts and budget handling.

Main responsibilities: Quality control of all Clinical Trials performed within R&D department, office staff training, quality assurance (preparation for audits/inspections, resolving of audits findings, compliance visits performing), office staff line management and couching. Additional responsibilities: Local SOP writing, quality risks and issues identification and corrective action planning and implementation to prevent or correct deficiencies in performance of staff. Acted as superuser for R&D department e-learning system. Responsible therapeutic areas/CT Phases: Rheumatology (Phase II - IV Studies), Oncology (Phase II – II Studies).

Main responsibilities: All aspects of clinical trials monitoring activities from study start-up to study closeout (study feasibility, initiation, management, regulatory and EC affaires, audit and inspections preparation, study closeout). Additional responsibilities: All regulatory interactions with local authorities for assigned studies (RA and EC submissions preparing). Contracts preparation and negotiation. Local and international meetings organization for clinical staff. Responsible therapeutic areas/CT Phases: Rheumatology (Phase II - III Studies).

Main responsibilities: All aspects of clinical trials monitoring activities from study start-up to study close-out (study feasibility, initiation, management, regulatory and EC affaires, audit and inspections preparation, study close-out). Additional responsibilities: Local safety report reviewer. Office staff training and couching. Responsible therapeutic areas/CT Phases: Cardiology (Phase II - IV Studies), Endocrinology (Phase III Study). Post – marketing studies experience.

Responsibilities: Patients treatment, HealthCare organization and planning activity.