Amgen CDM Systems Manager - Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
CDM Systems Manager - Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist
What you will do
Let’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
What we expect of you
We 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.
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 Or
Associate’s degree and 10 years of biopharmaceutical clinical research and/or project management experience Or
High school diploma / GED and 12 years of biopharmaceutical clinical research and/or project management experience
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
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and increase your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. 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.
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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.