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Manager, Csar - Global Library

4-12 years
₹25–35 LPA
10 May 24, 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
Work Location Type: On Site
Salary: ₹25–35 LPA (Estimated based on role and location)

Job Description:

Amgen is seeking a Global Library Manager to support clinical systems and analytical reporting within the Clinical Systems and Analytical Reporting (CSAR) team. Reporting to the Sr. Manager, this role is responsible for ensuring the proper development, management, and application of standard libraries and study-level database design in alignment with Amgen’s global standards and regulatory requirements.

Key Responsibilities:

  • Provide Global Library review and collaborate with Lead Data Managers to ensure adherence to Data Element Standards (DES)

  • Develop and maintain standard CRFs and Edit checks in RAVE CDMS or other EDC technologies

  • Deliver database design services to clinical study teams following global standards

  • Maintain consistency and quality in clinical trial platform technologies

  • Coordinate with cross-functional teams to ensure seamless delivery of CSAR activities and study support

  • Act as technical point of contact for system deliverables

  • Contribute to new systems, process improvements, and emerging technology implementations

  • Support audit readiness, including response preparation and process documentation

  • Assist in large system transformation projects via SME contribution, project management, and stakeholder engagement

Basic Qualifications:

  • Master’s degree in life sciences, computer science, business, or related field with 4–6 years of relevant experience

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

  • Diploma with 10–12 years experience

Preferred Qualifications:

  • Advanced degree in life science, computer science, statistics, or related fields

  • Strong experience in clinical data management/programming within pharmaceutical or biotech domains

  • Proficiency in project planning, vendor oversight, and clinical trial processes

  • Expertise in GCP, data standards (CDISC, SDTM), quality management, and risk analysis

  • Familiarity with clinical systems, including Rave EDC, Veeva EDC, and programming languages

Key Knowledge Areas:

  • Clinical trial databases and applications

  • Good Clinical Practice (GCP) and regulatory standards

  • Systems development lifecycle

  • Performance management techniques and problem-solving

  • Regulatory filings and process improvement methodologies

Why Join Amgen:

  • Be part of a biotech pioneer with a mission to serve patients with serious illnesses

  • Engage in an inclusive, science-driven, and collaborative culture

  • Work on life-changing treatments across four therapeutic areas

  • Receive comprehensive total rewards and benefits

  • Support for career growth, well-being, and professional development

Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Reasonable accommodation will be provided during the application and interview process as needed.

Apply now: careers.amgen.com