Job Title:
Lab Normal Range Coordinator
Location:
Hyderabad, India
Job ID: R-211152
Work Location Type: On Site
Date Posted: April 1, 2025
Category: Clinical
About Amgen:
Amgen is a global biotechnology pioneer committed to serving patients living with serious illnesses. With deep focus across four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—Amgen reaches millions of patients annually. With a collaborative, science-based culture, we support innovation, inclusivity, and integrity in every aspect of our work.
Role Summary:
The Lab Normal Range Coordinator is responsible for managing and maintaining laboratory reference ranges within Amgen’s Electronic Data Capture (EDC) systems. This role is critical to ensuring the accuracy and compliance of laboratory data in clinical trials. The coordinator provides subject matter expertise on lab data, reviews reference range documentation, and enters validated lab parameters and units into the EDC system, while resolving discrepancies in coordination with local labs and study teams.
Key Responsibilities:
Review and approve new laboratory parameters, units, and standard textbook ranges.
Serve as a subject matter expert on laboratory data interpretation.
Review and manage local and central laboratory reference range documentation.
Create laboratory IDs and input reference ranges and units for each lab analyte into the EDC system.
Identify, track, and resolve discrepancies in laboratory reference ranges.
Collaborate with cross-functional teams and participate in Data Management (DM) working groups.
Promote clinical data management best practices and process improvements.
Basic Qualifications:
You must meet one of the following educational and experience combinations:
Master’s degree in life sciences, computer science, business administration, or a related field with 1–3 years of relevant experience
Bachelor’s degree with 3–5 years of relevant experience
Diploma with 7–9 years of relevant experience
Plus:
2–4 years of direct experience in clinical data management or lab coordination
Must-Have Skills:
Expertise in clinical laboratory data and reference ranges
Familiarity with Good Clinical Practice (GCP)
Knowledge of clinical data management processes
Understanding of International System of Units (SI)
Familiarity with conversion factors and data normalization
Good-to-Have Skills:
Experience using EDC systems and developing Data Management Plans (DMPs)
Understanding of Electronic Medical Records (EMR)
Awareness of lab certifications and equipment calibration standards
Soft Skills:
Strong verbal and written communication skills
Attention to detail and critical thinking
Ability to work independently and within cross-functional teams
Equal Opportunity Employer Statement:
Amgen is an Equal Opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations are available for applicants during the hiring process.
Apply Now:
https://careers.amgen.com/job/R-211152/lab-normal-range-coordinator-hyderabad-india
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