Elena Kocev

- CDAs, MSA, Clinical Trial Service Agreements, etc. - Clinical trial start up activities, payments, project timelines, TMF management, Clinical Study Report - Site initiation, Interim & closeout monitoring visits - Trial medications (IMP, AxMP) management - Supporting Regulatory Affairs - Due diligence of in-licence dossiers - Compliance of the clinical operations - SOPs/ Procedures/ Guidelines - Managing deviations & CAPAs - Audit and inspection activities - Training program for clinical operation staff.

• Integrated Quality Management system (ISO 9001 Quality management system, ISO 14001 Environment protection, OHAS occupational health and safety of the personnel, GDP Good Distribution Practice, GDoP Good Documentation Practice; • Change control, deviation, and CAPA management; • Trainings; • Contracts and budget management; • Internal and vendor audits and regulatory inspections; • Project team member in specific company’s projects.

• Integrated QMS for quality management, environment protection, good distribution practice and health and safety of the personnel; • Trainings; • Deviation & CAPA management; • Internal and vendor audits, regulatory inspections; • Marketing Authorisation Applications for first MA and lifecycle of medicinal products, herbal medicinal products and medical devices; • Logistic support of clinical trials; • Contracts management; • Budget management.