• Participates in clinical trial scenario planning (estimates timeline and cost, requests internal resources)
• Works with Strategic resourcing team to select study vendors
• Oversees study vendors to ensure quality and delivery
• Oversees the development of and adherence to clinical trial project timelines
• Ensures senior Clinical Operation staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
• Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
• Ensures study plans (including but not limited to project plan, communication plan, issue escalation plan, clinical monitoring plan, medical monitoring plan, drug safety monitoring plan, data monitoring plan, Trial Master File plan and etc) are created, updated and distributed timely
• Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites
• Ensures site monitoring reports are accurate and reviewed on a regular basis
• Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) status
• Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis
• Reviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecast
• Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs, if required

上班地址：北京市朝阳区建国门外大街甲6号, 中环世贸中心D座