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Global Clinical Program Management Senior Manager Observational Resear

Company: Amgen
Location: Thousand Oaks
Posted on: March 18, 2020

Job Description:

Global Clinical Program Management, Observational Research as part of Global Development Operations, plays a meaningful role in ensuring the efficient and successful planning and execution of observational research studies globally, throughout the drug development lifecycle. The evidence generated through this observational research is used to support the value of Amgen's medicines.Reporting to the Director, Global Clinical Program Management (GCPM) for Observational Research, the Senior Manager, GCPM Observational Research, is an expert and skilled member of the GCPM team and collaborator across the Global Development organization, Medical and other key internal and external stakeholders. This role will be located on the Amgen corporate campus in Thousand Oaks, California.Responsibilities:Supports GCPM Director in the following activities:

  • Operational strategy, planning, risk assessment and mitigation, and overall execution for the observational research (OR) portfolio
  • High-quality execution of OR studies on time and within budget
  • Provide leadership and expertise on the regional Key Evidence Generation Teams (KEGs) and Evidence Generation Teams (EGTs)
  • Provide clinical operations leadership and expertise through the feasibility and study design process
  • Ensure compliance with Good Clinical Practice (GCP), Amgen SOPs and any applicable legislation
  • Maintain and improve global teamwork and consistency
  • Lead observational clinical study process development activities, including authoring and/or review of SOPs, Manuals, trainings and cross functional workstreams
  • Support GCPM resource planning for GCPM-OR in collaboration with Project Resourcing Lead and GCPM-DirectorBasic Qualifications:Doctorate DegreeORMaster's Degree and 2 years of Clinical experienceORBachelor's Degree and 4 years of Clinical experienceORAssociate's degree and 10 years of Clinical experienceOrHigh school diploma / GED and 12 years of Clinical experiencePreferred Qualifications:
    • BS/BA/BSc in the sciences or RN
    • 9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
    • Experience conducting and/or leading all aspects of observational research execution in an industry setting
    • Previous management experience of direct reports
    • Experience in using RWE cohorts and alternative data sources in clinical trials
    • Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc)
    • Experience driving and leading process development and /or improvementAmgen 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.Work alongside the best. Be part of our highly hardworking teams. Their spirit is what fuels our success.Join UsIf 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.

Keywords: Amgen, Thousand Oaks , Global Clinical Program Management Senior Manager Observational Resear, Executive , Thousand Oaks, California

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