Involve company pipeline development as senior management teamOptimize clinical operation team and assignment to significantly improve team performanceGenerate SOP framework and guide team on SOP development, training materials and internal administration tools and system from zeroSet up vendors selection strategy and processesCreate & streamline cross function cooperation processes and SOP Enhance collaboration with internal cross functions including R&D, translational medicine, clinical medical, quality, manufacture and supply chain etc. Outsource trials to CRO and approve clinical trial budget Oversee key projects delivery in GBM, NSCLC and pancreatic cancer area etc.Visit KOLs and GCP officers to expedite project deliveryResponsible for market & customer service function set-up and growth, liaison of collaboration between customer service and other functions including R&D, clinical operation, clinical medical, quality, manufacture and supply chain etc.

 Build up clinical operation functions & team build-up including PM, CRA, SSU, Assistants, QM Set up business related SOP, systems, and processes Lead clinical operation functions, ensure the functions can smoothly meet or outperform the function’s goals, all the business activities comply with ICH-GCP, Chinese legal/regulatory requirements and the Company’s policies and SOPs Develop and implement strategic tactics to ensure continuous productivity and efficiency improvements, and high-performance clinical operation teams; Design and lead innovative clinical services as company's key emerging business to differentiate from competitors Visit KOLs and top hospitals' GCP officers to facilitate project delivery Enhance relationship with clients to support business expansion Oversee key clients and pivotal projects

 Restructure China project management department and build up China PM team Oversee key global client accounts from client program development strategic early engagement to project delivery in Infectious diseases and gastroenterology Present China regulatory and clinical operation insights to PPD global executive management and global clients Oversee multiple projects in infectious disease  Engage KOLs and GCP officers to provide hands-on support to project team  Support business expansion in China

 Build up dedicated project delivery team from the scratch including study manager, CRA and CTA Develop BDU development strategy Develop BDU onboarding and training manual including technical & softskill aspects Generate BDU branding materials and promote it to APAC cross-functions  Design subject matter expert roadmap covering people management, project management, finance, RA, start-up, quality management, project assistant and tools/systems usage  Liaise with global PM training team, APAC PM and strategic lead groups to leverage global & regional resources and experiences  Work with global systems management team to integrate BDU requirements into global systems

Administrative Management Experience Manage PMs and project assistant in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. China oncology PM team lead liaising with APAC oncology group head. Greater China resourcing manager to coordinate CPM resources for BDM and replacement Streamline working instructions/processes working with cross-functions following China regulations.  Serve as primary PM function contact point for internal cross-functions and external clients to ensure appropriate communication channels are maintained and questions addressed. Organize and host PM function monthly office meeting for Great China Region  Act as senior oversight for assigned key clients from strategic early engagement to program close-out; oversee PMs on project delivery for GI, cardiovascular, oncology and CNS phase I to III studies, recommend courses of action regarding customer management issues.  Lead BD proposal development and face-to-face BD presentations as project director.

Administrative Management Experience Jointly hosted and passed the FDA inspection with NO findings Acting director during the absence of clinical operation director since 2011; Managed & mentored PMs, CRAs and CTAs on resource allocation, performance assessment and experience sharing; Acted as PM team lead to interact with cross functions to streamline procedures;  Summarized knowledge and practices of conducting clinical trial in China to corporate top management for international conferences; Developed training materials and delivered the training to global & regional PMs; Delivered project management presentation to external PM peers cross China through DIA PM Saloon; Prepared and attended client QA office audits and client office visits; Led feasibility, BD activities and attended project bid defences as key leader; Acted as global & regional PM to manage studies involving 9 countries in APAC

Administrative Management Experience Set up clinical operation department and adapted SOP system in China;  Recruited CRAs; designed and delivered training to CRAs; Proactively involved in Regulatory Affairs activities; China contact point Liaising with global R&D, clinical operation and QA departments; Involved in product pipeline discussion as Asia Pacific strategic key team member; Coordinated with AP cross-functional departments: R&D, RA and S&M; Enhanced positive relationship with current and potential clients; Evaluated external service vendors: QA, IP depot and DM & bio-statistic analysis; Optimized flow procedures of clinical research projects cooperating with customers; Provided training to Sales & Marketing staff;

 Coordinated between internal departments: QC, QA and plant; trained staff; Initiated and implemented validation protocols; Generated validation reports and reshuffled SOPs.

 Managed all office documents; Managed project and provided directions to local team members;  Liaised with sponsor and internal departments such as PV, Central Lab, IP depot and Database;  Designed and delivered training to CRAs; mentored junior CRAs;  Performed start-up activities: feasibility, preparation for EC submission and IM attendance; Conducted on-site visits from SIV to COV to ensure the trials adherence to ICH GCP, regulations, protocols and SOPs;  Involved in HQ’s audit for a Chinese pharmaceutical company in compliance with FDA cGMP;

Quality Manager Nov 1995 – Sep 1999 Led internal audit for pre-CFDA GMP inspection and obtained the GMP license; Involved in establishment of a new GMP company as key player, set up lab;  Initiated, reviewed and approved SOP;R&D Leader Jul 1992 – Oct 1995 Acted as PM Responsible for clinical trials in cardiovascular and infectious diseases;  Key player involving in pre-clinical development and regulatory affair activities.