RESPONSIBILITY: 1. Project planning—Create a project team, communicate final protocol and explain scientific approach/performance to the team (e.g. cost, time, quality). 2. Responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and timeline, and for managing the clinical portion of the study budget. 3. Project Problem Management—Suggest solutions and actions to solve study problems, manage the impact on time and cost, review protocol changes. 4. Responsible in resource allocation, task oversight and delegation, development of monitoring plans, contingency planning, and management of communications and reporting. 5. Provide clinical monitoring expertise and leadership for large, complex protocols and/or international programs. 6. Lead and motivate the clinical team. Act as a mentor and train CRA in the responsibilities of the position. 7. Assist in the development and implementation of plans associated with audits and regulatory inspections. 8. To ensure assigned projects excecute in accordance with related company SOP.
JOB REQUIREMENTS 1. Bachelor degree or above (Biology/ Medicine related). 2. 5 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field. 3. Experience in Phase II/III clinical project(Oncology study experience is preferred). 4. Prior project management experience is preferred. 5. Hard working ,good communication skills, able to work under project pressure.