Clinical Data Manager

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Clinical Data Manager

What you will do

Lets do this. Lets change the world. In this vital role you will be the Project Lead within Global Study Operations Data Management (GSO DM) and report to the Senior Manager-GSO Data Management. Amgen GSO-DM is strategically resourced with external vendor support through a functional service provider (FSP) model. The Data Manager taking this role will partner with cross functional study teams as well as the FSP to ensure product delivery of the Amgen Therapeutic Area portfolio.

Global Study Operations (GSO) Data Management plans and implements the capture, cleaning and storage of all Amgen clinical study and trial management data.

• Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks.
• Ensure that quality control checks are occurring such that quality databases are delivered.
• Develop and coordinate project level training for data management staff.
• Review and approve study specific training and lead vendor results and relationship at the project level.
• Communication of project level issues including processes, timelines, resourcing, performance, etc.
• Review of all study level non-DM documents for awareness and project level consistency.
• Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these 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
• High school diploma/GED and 10 years of experience

• Degree in life science, computer science, business administration or related field.
• Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry.
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)

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

for a career that defies imagination

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

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.