Clinical Data Management, Senior Manager
Job ID: R-115096
Location: Thousand Oaks, CA, US
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 Data Management, Sr. Manager
What you will do
Let's do this. Let's change the world. In this vital role you will manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit in partnership with a CRO in a fully outsourced business model. As well as lead CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery.
You will be a part of the Biosimilars group. Biosimilars are an important development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen developing biologics as well as our quality manufacturing while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate similarity to the originator product.
Management of biosimilars CDM activities and program(s), including system infrastructure and integration and maintenance of Sharepoint site permissions and content
- Input into group goals and objectives
- Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies
- Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs
- Ensuring delivery of quality clinical trial data, within agreed upon timelines
- Ensuring CDM processes/systems meet regulatory and business requirements
- Assist with CRO contracts and budgets
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Data Management professional we seek is an analytical leader with these qualifications.
- Doctorate degree & 2 years of directly related experience OR
- Master's degree & 6 years of directly related years experience OR
- Bachelor's degree & 8 years of directly related experience AND
- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Masters degree or equivalent in life science, computer science, business administration or related discipline
- 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.