Hunter Yu

Established healthcare digital business function focus on providing digital innovation solutions and consulting services to diverse clients in the healthcare domain. Developed a skilled digital service team including Solution development, Data mining & analysis, Project operation, and user training and support functions.

Responsible for the leaders of medical and scientific activities in assigned therapeutic areas （CNS&PC）with a focus on unmet medical need assessment, value proposition of s-a products, and the development and execution of medical strategy and plan to provide medical support to new and existing products in accordance with the Management's priorities and requirements, and in strict adherence to the Company's corporate policies, guidelines and requirements. Supervise health economics outcomes research (HEOR) team, Develop and execute health economics outcomes research plans, to optimize product value. Actively build up cross-functional strategic partnership – including medical excellence, pharmacovigilance, regulatory, clinical operations, R&D, marketing, sales and government affairs – to ensure integrated plans across these functions

Leading the China medical team to delivery all R&D studies China involved, and local PMS, ISS and IIT studies including study design, compliance, operation, timeline and budget management. Vender (CRO) selection, auditing, review study contract, payment approval and other operation activity. Working with local commercial team to provide an additional and important contact point for relationships with Key Opinion Leaders especially in the Cardiology, Neurology, Nuclear Medicine, Interventional Radiology and Urology specialties. Give support for IIT needs and doctor training for imaging technology. Responsible for department budget management staffing plan, to perform budget apply, review and performance appraisals and to develop and motivate team to meet the needs of both internal and external customers. Responsible for local Pharmacovigilance activities to provide advice/guidance regarding safety issues, in line with local regulations, to communicate effectively with regulatory affairs, and legal departments.

Providing professional CRO service to sponsors. Including medical writing, data management. And statistical support for clinical trials, developed a team made up by Medical manager, Data manager, statisticians and other players. Medical Department has a team with Medical managers/writers, statisticians, SAS programmers. Provided service including protocol, CRF, SAP, IVRS/IWRS, Study Report etc. Data management center equipped with Oracle Clinic also have experience with MEDIDATA and other EDC systems.

Involved in more than ten trials including some international multi-centre trials to handle data management issues. Collaborated with senior clinical trial manager to work on CRF development, Build up trial database from source data, resolve data errors by referring to source data or sending queries to research site. Used DATAFAX software to do study set up, data collecting, processing, validating, and sending QC Reports. Wrote SAS validation program (both standard and study-specific), Conducted program testing, export reviewing, data transporting, sampling, and data reconciliation. Wrote and run SAS program for trial related Payment Reports, QA Reports, Survey Reports, and other specific programming activity for different purpose