梦熊 王

Oncology portfolio and project management.

Provide portfolio management support and operational support for agreed projects in both early and late stage; Contributing to cross-functional change management initiatives, including key stakeholders from regulatory, clinical operations, safety and medical; Driving cross-functional regional planning at a project level; Applying best practice Project Management to Amgen's global Commercialization processes; Assisting with regional integration into global planning and prioritization processes; Driving key projects to educate global for China regulatory reform; Co-lead the project for China simultaneous development approach under new regulation;

Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Perform assigned administrative tasks to support team members with clinical trial execution.