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Sr Manager Clinical Operations & Oversight- COOSM

Amgen
Thousand Oaks, CA 91360
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    120135167
Amgen

Job ID: R-98722
Location: Thousand Oaks, CA, US 91360

Country/hub co-leader of Global Study Operations / Site Management (GSO-SM) organization that is accountable for timely, quality clinical study delivery and oversight of FSP vendor(s) Actively partners with cross-functional teams to support R&D strategy

Responsibilities
  • Co-Leadership of GSO-SM team in country/hub, as delegated by the DOM
    • Align and co-lead country/hub in accordance with Amgen strategy, driving One AmgenAlign and co-lead country/hub 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
    • Co-Accountable for country/hub operational landscaping activities and final site selection (final accountability relies on DOM)
    • Review and approve Operational Projections, Baseline and Revised Enrolment Plans
    • Represent GSO-SM in internal and external stakeholder interactions
    • Participate in external engagement activities (e.g. pharma associations, Consortiums)
    • Point for contact for resolution of sophisticated clinical study related issues & risks identified
  • 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 inspection readiness, internal/affiliate and site audits and regulatory inspections, including CAPA resolution
    • Actively participates cross-functional initiatives
    • Leads local process improvement initiatives
  • Performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP) (may only apply to specific local GSO-SM roles as delegated by the DOM)
    • For applicable roles, point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
    • Partner with DOM and SM-FSP line management to maintain appropriate resource levels and manage within budget
    • Ensure efficient resource allocation for applicable local GSO-SM roles
    • Supports SM-FSP staff onboarding and training
  • Locally accountable for execution of clinical studies
    • Support local delivery of pipeline molecule programs
    • Performs sponsor oversight activities of SM-FSP, including capacity planning and management, staff training and performance, to ensure quality and delivery of Amgen clinical trials, as outlined in quality oversight plan
    • Oversight of the site contracting, budgeting and payment process
    • Ensure timely, quality communication to both functional / cross-functional teams to support clinical study execution
    • Partner with GSO-SM FSP and GCPM organization to supervise study progress and drive local action plans & issue resolution
    • Support ISS execution
    • Provide local expertise through tools or upon request
  • 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


Basic Qualifications

Doctorate degree and 2 years of clinical research experience at a biotech, pharmaceutical or CRO company.

Or

Master's degree and 6 years clinical research experience at a biotech, pharmaceutical or CRO company.

Or

Bachelor's degree and 8 years of clinical research experience at a biotech, pharmaceutical or CRO company.

Or

Associate's degree and 10 years clinical research experience at a biotech, pharmaceutical or CRO company.

Or

High school diploma / GED and 12 years clinical research experience at a biotech, pharmaceutical or CRO company.

And

2 years of supervisory experience directly managing people and/or leadership experience leading teams, projects, programs or advising the allocation of resources

Preferred Qualifications

M.D., D.O., PhD, 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.



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Posted: 2020-05-07 Expires: 2020-06-07

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Sr Manager Clinical Operations & Oversight- COOSM

Amgen
Thousand Oaks, CA 91360

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