Job Information
Amgen Global Study Operations China Head in Shanghai, China
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