Andrey Gurachevsky

Managing Phase I-II (oncology) studies: from study concept to reporting/archiving; Leading project teams, investigational sites, CROs and vendors towards achieving milestones; Coordinating submission and reporting to authorities and ethics committees; Developing strategies for sponsor oversight, trial specific plans and procedures; Managing budget, work/change orders, forecasts and costs management; Overseeing trial documentation; Drug supplies and lab services. Support to QA/AM, process improvement

Project leader for full cycle of drug supply chain (forecasting, manufacturing/sourcing, cold chain distribution, handling at investigational hospitals) in biosimilars clinical programs (oncology, RA, CKD), Phases I to III; Sponsor oversight of drug handling at manufacturers, depots and sites; Preparation for and participation in audits and regulatory inspections; Leading departmental process improvements; Design and roll out of electronic systems Process harmonization with strategic suppliers

Trainer/Consultant (Interactive response Systems, Project and trial management systems, warehousing systems and interfaces); Product manager of novel IT solutions for clinical supplies; Leading and contributing to ongoing process improvements and external partnerships and alliances

Leading international project teams for clinical supplies within clinical trials (oncology, COPD); Leading work streams in alliances and partnerships with suppliers (Manufacturing, Depots, Couriers, Wholesalers); Standardization of study processes and design of SOPs; SME / Trainer (third-party supplier management, import/export management, study blinding)

- Planning/conducting experiments - Programming / database management - Development technical documentation according ISO - Design of SOPs and analytical methods - Preparing of reports and publications

Strategy Project/Change management Managing people Entrepreneurship Finance Marketing Sustainability

Radiation ecology, physics, ecology, radiation protection, information technology