• Direct oversight of FSP resources dedicated to major Pharma company • Selection and onboarding of new employees • Provide training and perform accompanied visits with CRAs • Conducting RCA for study related issues, developing CAPA and following up its resolution. • Oversee performance and training compliance • Address and manage employee performance issues • Dedicated local point of contact for all client operational and performance related matters For internal projects: • CA dossier preparation, submission and following up to approval. • Safety reporting to CAs. • Feasibility processes

• Maintain timely and effective communication among team members • Identify potential issues and implements corrective actions • Assure compliance with local regulations, CFR/ GCP guidelines, SOPs • Perform training and assessment visits for less experienced CRAs • Country coordinating activities for phase III international trial • Clinical monitoring and site management activities • Site selection and feasibility studies

• Ensure appropriate employee resources are available to meet corporate/project objectives • Mentor and develop employees to expand employee performance levels. Functions of external CRA manager for US pharmaceutical company (covering activities in Russia, Ukraine and Poland). • Ensure all projects are managed according to contractually schedules and budgets • Ensures services provided to clients are compliant with company policies, procedures, international standards and country specific regulatory requirements • Manages the client relationship to assure client satisfaction • Conducting PM functions, as required

Management of human and material resources to initiate and conduct clinical trials Project management and clinical monitoring Site selection and feasibility studies Investigator Meeting preparation and handling Liaison with regulatory authorities and investigational sites administration Safety data processing and notification to authorities Sub-contractors negotiation and management Established and maintained a representative office of German CRO

Clinical monitoring Project management

Management and monitoring of international clinical trials Designing and implementation of local pre-registration and post-marketing studies Preparation of scientific and marketing materials Presentations at conferences and liaison with OLs Support to marketing and sales departments Support in drug registration