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Global Study Operations China Head

2 months ago

Shanghai, China Amgen Full time

Purpose / Accountabilities

  • Country/hub leader of Global Study Operations / Site Management (GSO-SM)

organization that is accountable for timely, quality clinical study delivery.

  • Actively partners with cross-functional stakeholders to support R&D strategy.

Responsibilities

  • Leadership of GSO-SM team in country/hub

  • Align and lead country /hub in accordance with Amgen strategy, driving One

Amgen-

  • Supporting-leading local and global process improvement & transformational

initiatives

  • Developing strategy for study placement in country/ hub and maintaining

knowledge of the country capabilities

  • Accountable for country/hub operational landscaping activities and final site

selection

  • Review and approve Operational Projections, Baseline and Revised EnrolmentPlans

  • Represent GSO-SM in internal and external stakeholder interactions

  • Participate in external engagement activities (e.g. pharma associations,

Consortiums)

  • Point for escalation for resolution of complex clinical study related issues & risks identified

  • Locally accountable for execution of clinical studies

  • Lead delivery of pipeline molecule programs

  • Ensure timely, quality communication to both functional / cross-functional teams to support clinical study execution

  • Partner with GSO-SM FSP and GCPM / Early Dev Clin Ops organization to monitor study progress and drive local action plans & issue resolution

  • Support ISSs execution & partner with medical to design and execute LASTs

  • Provide local expertise through tools or upon request

  • Risk mitigation and quality management

  • Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness

  • Interpret analytics to monitor clinical study delivery (timelines, enrollment, data flow,

TMF)

  • Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations

  • Support internal/affiliate and site audits and regulatory inspections

  • Support local and global process improvement initiatives

  • Performance management of local staff and oversight of GSO-SM Functional

Service Provider(s) (FSP)

  • Partner with RH to maintain appropriate resource levels and manage within

budget

  • Interpret resource supply and demand and ensure efficient resource allocation

  • Engage local cross-functional teams to maximize local support of clinical studies

  • Maintain relevant therapeutic knowledge and clinical research best practices

  • Provide information and request support as needed