Clinical Data Management Manager

Clinical Data Management Manager Opportunity at Amgen

Career Category: Clinical

Job Description

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 as a Clinical Data Management Manager.

LIVE – What You Will Do

In this vital role, you will be responsible for ensuring clinical projects are executed according to set timelines with quality and consistency. Depending on the complexity, the successful candidate may oversee one or multiple products. Key responsibilities include, but are not limited to:

• Project level coordination and day-to-day oversight of Data Management (DM) tasks.
• Review all DM documents within a project to ensure a consistent approach.
• Review project timelines and metrics to ensure databases are delivered on time.
• Approve database locks and unlocks, ensuring quality control checks.
• Develop and coordinate project level training for DM staff.
• Lead vendor results and relationship management at the project level.
• Communicate project level issues, including processes, timelines, resourcing, and performance.
• Review all study-level non-DM documents for awareness and consistency.
• Lead electronic submission activities and assist with responses to audits and quality assurance questions.
• Participate in the development, review, and implementation of DM processes, policies, SOPs, and associated documents.

Be Part of Our Team

You will be joining the Clinical Data Management team, a global group that operates from Uxbridge and Cambridge in the UK, as well as Thousand Oaks and San Francisco in the US. The team is part of Global Study Operations, which comprises both Data Management and Site Management. We work together to meet the demands of an industry-leading, fast-paced organization with a commitment to innovation and quality.

WIN – What We Expect of You

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:

• Degree in life science, computer science, business administration, or a related discipline.
• Broad and proven experience in life sciences or a medically related field, including biopharmaceutical clinical research experience.
• Extensive Data Management experience in a global organization.
• Experience at or oversight of outside clinical research vendors (CRO’s, central Labs, vendors, etc.).
• Knowledge of Good Clinical Practice, Drug development, and clinical trials processes.
• Familiarity with clinical trial databases and applications, Quality Management, Regulatory filings and inspections, Risk analysis, and Process improvement methodologies.

THRIVE – What You Can Expect of Us

As we work to develop treatments that care for others, we also focus on the professional and personal growth and well-being of our teammates. You can expect:

• Vast opportunities to learn and advance in our global organization.
• A diverse and inclusive community where teammates are empowered to share ideas and take action.
• A generous Total Rewards Plan comprising health, finance, and wealth, work/life balance, and career benefits.
• The ability to work flexibly from home with regular office work at our Cambridge or Uxbridge next-generation workspaces.

APPLY NOW 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 at .

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