Job Title: Lab Normal Range Coordinator
Department: Clinical
Company: Amgen
Location: Hyderabad, India
Work Location Type: On Site
Date Posted: April 1, 2025
Application Deadline: Not specified
Job ID: R-211152
Job Summary:
Amgen is hiring a Lab Normal Range Coordinator to manage and maintain laboratory reference ranges within the Electronic Data Capture (EDC) system. This role requires providing subject matter expertise on laboratory data, verifying lab documentation, creating lab IDs, entering analytical units and ranges, and resolving discrepancies across local laboratories. You’ll also support data management and cross-functional collaboration to promote best practices.
Key Responsibilities:
Approve new lab parameters, units, and textbook reference ranges.
Provide expert advice on laboratory data.
Review reference range documents from local and central laboratories.
Create lab IDs and input values into EDC systems.
Identify and resolve inconsistencies in lab reference ranges.
Highlight issues and risks related to laboratory data management.
Collaborate in data management and cross-functional working groups.
Advocate for best practices in clinical data management internally and externally.
Basic Qualifications:
Master’s degree in life science, computer science, business administration, or related discipline with 1–3 years of experience OR
Bachelor’s degree with 3–5 years of relevant experience OR
Diploma with 7–9 years of relevant experience.
Required Experience:
2–4 years in clinical data management or laboratory coordination.
Strong understanding of laboratory data and clinical reference ranges.
Familiarity with Good Clinical Practice (GCP).
Understanding of clinical data management processes.
Knowledge of SI units, conversion factors, and comparability of results.
Preferred Skills:
Experience with EDC systems and data management plans (DMPs).
Understanding of Electronic Health Records (EHR).
Awareness of lab certification and equipment calibration standards.
Soft Skills:
Strong communication and collaboration abilities.
Attention to detail with sound analytical and problem-solving skills.
Capable of working independently and within a team environment.
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer. Applicants are considered without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, veteran or disability status. Reasonable accommodations are available for individuals with disabilities.
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