Sr Mgr Clinical Development Operations

Category: Clinical
Job ID: R-35421
Location: China – Hong Kong
Posted Date: March 9, 2017
Country/hub leader for 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
Leadership of GSO- SM team in county hub:
Oversight of local strategy including feasibility and country operational
Accountable for local feasibility activities and approve final site selection
Review and approve forecast, baseline and re-baseline study targets
Accountable for execution of clinical studies
Ensure timely collection and validation of clinical trial data
Responsible for timely, quality communication to both functional/ cross functional teams to support data monitoring, flow and validation activities
Partner with GSO-SM FSP and GCPM organization to monitor study progress and drive local action plans
Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations
Risk Mitigation and Quality Management
Proactively identifies risk and develops risk mitigation strategies to ensure operational effectiveness
Interpret analytics to monitor clinical study delivery (timelines, enrollment, data flow)
Representing GSO-SM in internal and external stakeholder interactions
Performance Management of Local Staff and Oversight of GSO-SM Functional Service Provider(s) (FSP)
Partner to maintain appropriate resource levels and manage within budget
Supporting local and global process improvement initiatives
Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and local regulations
Engage local cross-functional teams (eg. Medical, Scientific Affairs, GRASS) to maximize local support of clinical trials
Maintain relevant therapeutic knowledge and clinical research best practices
Participate in external industry activities (eg. pharma associations, regulatory agencies)
Basic Qualifications
Work experience in life sciences or medically related field, including biopharma clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharma or CRO company)
Previous management experience of direct reports including management level staff
Preferred Qualifications:
MD/PHd/DO/PharmD/Master’s Degree
Experience at or oversight of clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Country clinical operations experience and/or regional study management experience
Advanced knowledge of global clinical trial management
Clinical trial processes and operations
Extensive knowledge of ICH/GCP, local regulations, clinical trial environment, requirements and guidelines
Project and program management experience including oversight of quality, study deliverables, budgets and timelines
Various TA knowledge
Fluency in English
Clinical trial management systems experience and reporting tools
Eligibility to work in Hong Kong