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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