• Hiring, onboarding, training, development and performance management of CRAs in Europe (Poland, UK, Germany, Spain, France, Italy, Croatia, Serbia)• Management of contracted CRAs in EU and APAC (provided by vendors and individual contractors); involved in contracting and invoice review• CRA resource allocation• Oversight and conduct of the Monitoring Evaluation visits• Assistance in the development of department quality standards and programs.• Developing infrastructure/SOPs/processes and working guidelines for the function to meet regulatory, ethical and clinical standards• Developing benchmarks for tasks regarding time, budget, quality; and report on departmental KPIs• Assistance to the Line Managers and other Clinical Operations staff in leading cross-functional project teams to meet the project timelines and deliverables.• Supporting the Clinical Operations Department for proposals, budgets development and other pre-award activities

• Serve as the main point of contact for CRAs for any non-project specific needs• Manage performance and support training needs and growth opportunities of CRAs• Communicate regularly with CRAs to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives • Support Resourcing team by assisting with resource planning for new projects• Support to determine and operationalize corporate strategy and vision for the continued growth.• Participate in activities related to CRA recruiting, interviewing and hiring.• Conduct new employee orientation and onboarding.• Perform accompanied quality assessment visits to assess CRA performance and conduct other visits as needed.• Assist in the development of quality standards and programs

- Responsible for the selection, training, development, and performance management of CRAs/CTAs;- Responsible for staff time management, PTO and salary reviews;- Promote project-specific quality and performance standards for clinical trial administration and/or clinical monitoring and ensure these are adequately documented, communicated and understood by all members of team (Russia and Belarus);- accompany CRAs on site visits to ensure that study related activities are conducted according to study requirements, relevant SOPs, guidelines and regulations;- Ensure that staff billable rates are maintained at the required levels and that overall average effort rates do not exceed acceptable limits;- Liaise with other departmental managers to assess staff allocation and to identify the appropriate project team members available for potential/awarded studies. Maintain a staff allocation database;- Identify, develop, and implement measures to improve the efficiency of the department including notification of problems.

- Responsible for the selection, training, development, and performance management of CRAs/CTAs;- Responsible for staff time management, PTO and salary reviews;- Promote project-specific quality and performance standards for clinical trial administration and/or clinical monitoring and ensure these are adequately documented, communicated and understood by all members of team (Russia and Belarus);- accompany CRAs on site visits to ensure that study related activities are conducted according to study requirements, relevant SOPs, guidelines and regulations;- Ensure that staff billable rates are maintained at the required levels and that overall average effort rates do not exceed acceptable limits;- Liaise with other departmental managers to assess staff allocation and to identify the appropriate project team members available for potential/awarded studies. Maintain a staff allocation database;- Identify, develop, and implement measures to improve the efficiency of the department including notification of problems.

- coordination, execution, control and completion of clinical trials at country level - Russia and Ukraine (oncology, hematology, renal disease)- management of several clinical teams to provide quality and achieve key metrics

Sponsor-dedicated CRA (Amgen): Ensure that clinical research studies are conducted inaccordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements