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Clinical Data Management, Senior Manager

4 months ago

Washington, Washington, D.C., United States Amgen Full time

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.

Clinical Data Management, Senior Manager

Live

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.

Responsibilities:

  • 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

Win

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.

Basic Qualifications:

Doctorate degree and 2 years of clinical data management experience

Or

Master's degree and 4 years of clinical data management experience

Or

Bachelor's degree and 6 years of clinical data management experience

Or

Associate's degree and 10 years of clinical data management experience

Or

High school diploma / GED and 12 years of clinical data management experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

  • Master's degree or equivalent in life science, computer science, business administration or related discipline
  • 10 years of work experience in data management in the Pharmaceutical or Biotech arena
  • 3+ years of experience in a global organization
  • Previous experience at or oversight of outside clinical research vendors (CRO's, central labs, imaging vendors, etc.)

Thrive

What you can expect of us

As 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 now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 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.