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1 Clinical Development Operational Activity ? Manage all assigned clinical programs run locally in China, or in support of the global studies being run in China to ensure clinical studies are effectively managed. ? Work closely with all areas across Clinical Development to leverage the scale and operating model of the global organization (e.g., governance, ESP selection and oversight). ? Actively manage organizational effectiveness and address challenges that are impeding operational delivery. ? Provide expertise and guidance to global teams for operational execution and to allow the most compliant and efficient filing with the CDTA and appropriate regulatory agencies. ? Continually assess operating procedures and take action to drive on-going quality improvement. Align best practices with the global CDO organization. 2 Strategic Planning ? Provide operational input into local and global Clinical Development Plans, including best approaches for Chinese site and patient recruitment; ensuring expectations for local regulations are met; and aligning with global objectives, timelines and budget. ? Provide feasibility assessments for study conduct in Chinese sites 3Financial & Resource Management ? Develop and manage China clinical trial services budget to ensure strategic spending with External Service Providers. ? Efficiently use internal resources as well as accurate forecasting across the Clinical Development portfolio of China studies. Provide input to the global studies, as appropriate. ? Ensure assigned Clinical Programs are adequately resourced and lead the prioritization of work and resources across Clinical Programs in China. ? Create and optimize a scalable resourcing strategy to support seamless delivery of clinical studies with a combination of internal and external resources. 4 Quality Operations ? Ensure all areas of accountability are compliant with procedural requirements; ICH/GCP guidelines; C-GCP-like; and other local and national regulatory standards and requirements. ? Ensure China Clinical Development Operations input into investigations and followupactivities for all clinical CAPAs involving clinical programs run locally in China and global studies being run in China. ? Ensure coordinated relationship with CQCC and CQA to drive inspection readiness and overall quality of clinical studies. 5 External Relationship Development ? Manage strategic vendor relationships to ensure consistent delivery of contracted services through direct communication with key vendor’s executive management. ? Drive continuous improvement, cost savings and innovation in local CRO relationships. Oversee active governance for CRO relationships. ? Manage overall approach for cultivating relationships with KOLs and study sites in China to enable company to be sponsor of choice for clinical development