Amgen Clinical Systems and Analytical Reporting (CSAR) Study Design and Programming Sr. Manager in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Clinical Systems and Analytical Reporting (CSAR) Study Design and Programming Sr. Manager
What you will do
Let’s do this. Let’s change the world. In this vital role you will plan and oversee implementation of Clinical Systems and Analytical Reporting (CSAR) key operations/activities, participate in determining and setting vision and strategy and direction for the Study Design and Programming operations, and lead departmental or cross functional initiatives or projects.
The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables with functional service providers, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverable oversight of external vendors or partners. The CSAR Sr. Manager will also be expected to help deliver large system transformation projects, with focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management.
Provide line management and coaching staff to develop and grow their careers
A leader for specific CSAR core competency areas in partnership with Functional Service Provider; e.g. study database design and build, eCOA, etc.
Contribute to development of outsourcing strategies and long-term relationships with insourcing/outsourcing partners
Lead or contribute to develop and implement strategic direction of CSAR and the wider GDO organization.
Lead or contribute to key or interdepartmental initiatives / projects with particular focus in system or process improvements.
Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards.
Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment.
Ensure documentation support CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes.
Develop, review and implement policies, SOPs and associated documents
Assist in preparing for and responding to audit findings (internal or external).
Act as SME and provide coaching and mentoring to internal staff or providers.
Good Clinical Practice
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Clinical Systems landscape and/or Analytical platforms/reporting technology
Understanding of managing and providing oversight of operations with FSP/MSP or other vendor service provider model.
Drug development and clinical trials processes
Clinical trial databases and applications
Systems development lifecycle
Project planning and management
Collaborating and leading global cross-functional teams (team/matrix environment)
Quality management and Risk Analysis
Regulatory filings and inspections
Process improvement methodologies
Management of external suppliers
Setting goals and training plans to maximize talent management/career development of staff
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Doctorate degree OR
Master’s degree & 3 years of clinical experience OR
Bachelor’s degree & 5 years of clinical experience OR
Associate degree & 10 years of clinical experience OR
High school diploma / GED & 12 years of clinical experience
Experience in direct line management and Global teams
Master’s degree or equivalent in life science, computer science, business administration or related subject area
10 years work experience in data management in the Pharmaceutical or Biotech arena
3+ years experience in a global organization
Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc)
What you can expect of us
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.
Vast opportunities to learn and move up and across our global organization
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
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen 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 a 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 an accommodation.
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.