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Clinical Data Management, Senior Manager

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
May 21, 2024

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Clinical Data Management, Senior Manager

Live

What you will do

Lets do this. Lets 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

Masters degree and 4 years of clinical data management experience

Or

Bachelors degree and 6 years of clinical data management experience

Or

Associates 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 (CROs, 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.

careers.amgen.com

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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