Lab Normal Range Coordinator

Career Category

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.

What you will do

Let’s do this. Let’s change the world. In this vital role you will responsible for managing and maintaining laboratory reference ranges in the Electronic Data Capture (EDC) system. This role involves providing subject matter expert advice on laboratory data, reviewing local and central laboratory reference range documents, creating lab IDs, and entering the ranges and units for each analyst into the EDC system. This individual also identifies and helps resolve discrepancies in local laboratory reference ranges.

Roles & Responsibilities:

• Approve new lab parameters, new units, and textbook ranges.

• Provide subject matter expert advice on laboratory data.

• Review local and central laboratory reference range documents.

• Create lab IDs and enter the ranges and units for each analyst into the EDC system.

• Identify and help resolve discrepancies in local laboratory reference ranges.

• Communicate and call out day-to-day issues and risks regarding the area of work.

• Participate in DM and cross-functional working groups.

• Promote and advocate for data management best practices internally and externally.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications:

• Master’s degree and 1 to 3 years of life science, computer science, business administration or related discipline or equivalent experience OR

• Bachelor’s degree and 3 to 5 years of life science, computer science, business administration or related discipline or equivalent experience OR

• Diploma and 7 to 9 years of [life science, computer science, business administration or related discipline or equivalent experience.

• 2-4 years of related experience in clinical data management or laboratory coordination.

Must-Have Skills:

• Strong understanding of laboratory data and clinical reference ranges.

• Knowledge of Good Clinical Practice

• Understanding of clinical data management processes

• Understanding of International laboratory unit standards such as the International System of Units (SI)

• Understanding of concept of conversion factors and comparable results

Good-to-Have Skills:

• Familiarity with electronic data capture (EDC) systems and data management plans (DMP).

• Understanding of Electronic Health Record (EMR) Systems

• Understanding of Laboratory Certification

• Understanding of Laboratory Equipment Calibration

Soft Skills:

• Excellent communication and collaboration skills.

• Detail-oriented with strong analytical and problem-solving abilities.

• Ability to work independently and as part of a team.

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 that individuals with disabilities are provided with 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 an accommodation.