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
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