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Lab Normal Range Coordinator

3-5 years
Not Disclosed
10 June 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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