Clinical Data Manager (US-Remote)

Career Category

Clinical

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Data Manager

What you will do

Let’s do this. Let’s 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.

Specific responsibilities include but are not limited to:

• 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 co-ordinate 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.

Basic Qualifications:

Doctorate Degree

Or

Master's Degree and 2 years of clinical experience

Or

Bachelor's Degree and 4 years of clinical experience

Or

Associate's degree and 8 years of clinical experience

Or

High school diploma/GED and 10 years of clinical experience

Preferred Qualifications:

• 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 (CRO’s, central labs, imaging vendors, etc.).

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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
• Flexible work models, including remote and hybrid 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

Application deadline

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

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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. 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.

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Salary Range

118,946.00 USD - 144,923.00 USD