Clinical Data Manager

Clinical Data Manager Opportunity at Amgen

Career Category: Clinical

Job Description:

Defy Imagination with Amgen

Your hard work and dedication have brought you to this point in your career—now it's time to take the next step. How will you leverage your skills, experience, and passion to achieve your goals? At Amgen, our mission is to serve patients, a principle that drives everything we do. As one of the world's leading biotechnology companies, we have touched the lives of over 10 million patients globally. Join our team of innovative, driven professionals and make a meaningful impact in this critical role as a Clinical Data Manager.

Role: Clinical Data Manager

Responsibilities

We are seeking a dynamic Clinical Data Manager to join our Global Study Operations Data Management (GSO DM) team. In this crucial role, you will serve as the Project Lead and report to the Senior Manager of GSO Data Management. Working within a strategic functional service provider (FSP) model, you will collaborate with cross-functional study teams and external vendors to ensure the successful delivery of Amgen's Therapeutic Area portfolio.

Key Responsibilities Include:

• Project-level coordination and daily oversight of Data Management (DM) tasks.
• Review and ensure consistency of all DM documents within the project area.
• Monitor project timelines and metrics to ensure timely database delivery and approve database locks/unlocks.
• Ensure quality control checks to deliver high-quality databases.
• Develop and coordinate project-level training for DM staff.
• Review and approve study-specific training; lead vendor performance and relationship management at the project level.
• Communicate project-level issues, including processes, timelines, resourcing, and performance.
• Review non-DM study documents for awareness and project-level consistency.
• Lead electronic submission activities and assist in addressing Clinical Quality Assurance queries and audit responses.
• Participate in the development and implementation of processes, policies, SOPs, and other DM-related documentation.

Qualifications

We value diversity and seek professionals who bring unique contributions to our mission of serving patients. The ideal candidate is a proactive individual with the following qualifications:

Basic Qualifications:

• Doctorate Degree OR
• Master's Degree and 2 years of clinical experience OR
• Bachelor's Degree and 4 years of experience OR
• Associate's Degree and 8 years of experience OR
• High School Diploma/GED and 10 years of experience

Preferred Qualifications:

• Degree in Life Science, Computer Science, Business Administration, or a related field.
• Experience in Clinical Data, Project, and Planning Management in the Pharmaceutical or Biotech industry.
• Experience in overseeing external vendors such as CROs, central labs, and imaging vendors.

What You Can Expect From Us

At Amgen, we are committed to the professional and personal growth of our team members. We offer a comprehensive benefits package designed to support you and your family, including:

• Health and welfare plans for staff and eligible dependents.
• Financial plans with opportunities to save for retirement and other goals.
• Work/life balance and career development opportunities.
• Comprehensive employee benefits, including a Retirement and Savings Plan with generous company contributions, and group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• A discretionary annual bonus program or sales-based incentive plan for field sales representatives.
• 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.

Join us for a career that defies imagination. The future is closer than you think. Apply now at .

Amgen is an Equal Opportunity employer. We welcome candidates regardless of