Amgen

Senior Manager Clinical Data Management

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 04, 2021
Ref
R-116117
Required Education
Bachelors Degree
Position Type
Full time

The Senior Manager, Therapeutic Areas (TA) will partner with cross functional study team, as well as, FSP to ensure delivery of the Amgen TA portfolio. You will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, Global Study Operations (GSO). You will focus on timely quality delivery, as well as, consistency across the Data Management (DM) components.

Responsibilities:

  • Through cross-portfolio review, ensure delivery of all timelines and deliverables for the GSO-DM components
  • Plan and lead all aspects of GSO-DM activities for various TA products, projects, vendors or services
  • Risk Management
  • Resource Management
  • Strategic Portfolio Management
  • Quality Management
  • Stakeholder Management
  • Point of Critical issue
  • Assist various TA product teams in addressing process issues etc
  • Responsible for staff recruitment, management and development, as well as, staff performance in-line with Amgens process
  • Provide mentorship to staff and lead by example
  • Act as an SME across projects to ensure best practices in all GSO-DM processes and to ensure consistency within and across programs
  • Identify process improvement opportunities and drive forward
  • Evaluate the resourcing levels in partnership with FSP to ensure appropriate distribution and accountability for delivery of the portfolio demands.
  • Ensure GSO-DM processes are appropriately developed and are clearly communicated, with an eye toward continuous improvement of performance measures
  • Cultivate and maintain effective partnerships and knowledge transfers across Amgen.
  • Stay abreast of industry developments in the Data Management field and apply to appropriate systems or processes
  • Define and contribute in the process and/or technical implementation of DM and the wider GSO Strategies
  • Lead and/or participate in cross functional key projects and/or working groups
  • Develop, review and implement policies, SOPs and associated documents affecting DM globally
  • Provide technical and business process input / expertise and leadership on process improvement activities, new and emerging technologies

Basic Qualifications:

Doctorate degree and 2 years of clinical experience

Or

Masters degree and 5 years of clinical experience

Or

Bachelors degree and 7 years of clinical experience

Preferred Qualifications:

  • Masters degree or equivalent in life science, computer science, business administration or related subject area
  • 10+ years 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 (CROs, central labs, imaging vendors, etc)

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. #GDO2021.


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.