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Manager, Csar - Global Library

6-8 years
Not Disclosed
10 May 1, 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: Manager, CSAR – Global Library

Location: India – Hyderabad (On Site)
Job ID: R-213937
Date Posted: April 25, 2025
Category: Clinical
Company: Amgen


Job Summary

Amgen is hiring a Global Library Manager within the CSAR (Clinical Systems and Analytical Reporting) team. The role involves supporting clinical trial platforms, managing standard libraries, designing CRFs and edit checks in CDMS (e.g., Rave EDC, Veeva EDC), and contributing to clinical systems projects. The position is expected to work closely with data managers and cross-functional teams.


Key Responsibilities

  • Support clinical platform technologies and database design.

  • Act as a data scientist to provide analytical insights.

  • Coordinate programming support and ensure standards adherence.

  • Maintain compliance with regulatory standards and SOPs.

  • Provide technical input for emerging technologies and system transformations.

  • Respond to audits and ensure data quality at the study/library level.


Qualifications

Basic Qualifications

  • Master’s degree with 4–6 years experience OR

  • Bachelor’s degree with 6–8 years experience OR

  • Diploma with 10–12 years experience
    (In life sciences, computer science, business admin, or related fields)

Preferred Qualifications

  • Advanced degree in life science, statistics, computer science, etc.

  • Experience in data management and clinical programming (Pharma/Biotech)

  • Familiarity with:

    • GCP and drug development lifecycle

    • CDISC, SDTM standards

    • EDC systems (Rave, Veeva)

    • Vendor oversight and regulatory compliance

    • Project planning and systems development lifecycle


What Amgen Offers

  • Competitive salary and benefits

  • A collaborative, science-based culture

  • Opportunities for career growth and impact in a global biotech leader


How to Apply

Visit: careers.amgen.com