HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Electronic Clinical Outcomes Assessments (eCOA) Technical SpecialistLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will serve as an Amgen electronic Clinical Outcomes Assessments (eCOA) Technical Specialist and Governance Lead for Amgen’s eCOA providers.
Serves as the collaborate with external eCOA providers and internal cross functional teams as the Governance Lead for the eCOA organization
Serves as an Amgen eCOA Technical Specialist within the CSAR - System Study Services group
Accountable for quality delivery and competencies within the eCOA service area
Lead all aspects of study level system requirements meetings with eCOA vendors and internal partners.
Assist in the design and development of study specific technical documents
Support the internal team in managing project related timelines and associated activities
Partner with data management (DM) to define the requirements for data transfers
Work with external resources to lead the creation and implementation of user acceptance tests Identify and track study-related technical issues to resolution
Provide a supportive framework for continuous process and quality improvements
WinWhat we expect of youWe are all different, yet we all use our outstanding contributions to serve patients. The strong professional we seek is a subject matter authority with these qualifications.Basic Qualifications:
Doctorate degree Or
Master’s degree and 3 years of biopharmaceutical clinical research and/or project management experience Or
Bachelor’s degree and 5 years of biopharmaceutical clinical research and/or project management experience
Preferred Qualifications:
Bachelor degree or equivalent in life science, computer science, business administration or related subject area
Broad experience within quality management or oversight of external providers
Expansive experience in life sciences or a medically related field including experience in biopharmaceutical clinical research
Experience Electronic Clinical Outcome Assessments and vendor oversight
Effective partnering and client leadership skills creating productive engagement capabilities to meet collaborators and clinical study teams
Experience and ability to build and effectively present concepts and materials to senior management levels
Project management and technical expertise, attention to detail, and excellent documentation and interpersonal skills
Excellent time management and organization skills Sound problem resolution, judgment, and decision-making abilities
Able to work well in a global team-based matrix environment with minimal direction Knowledgeable in Good Clinical Practices, and Global Regulatory regulations
ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
