Job Title:
Manager, CSAR – Global Library
Location:
Hyderabad, India
Job ID: R-213937
Work Location Type: On Site
Date Posted: April 25, 2025
Category: Clinical
About Amgen:
At Amgen, we are committed to transforming the lives of patients suffering from serious illnesses. With deep expertise in biotechnology and a focus on Oncology, Inflammation, General Medicine, and Rare Diseases, we serve millions of patients globally. Amgen fosters a collaborative, science-based, and innovative work culture that encourages talent development and ethical excellence.
Position Overview:
The Manager, CSAR – Global Library will support clinical trial operations through expert database design and Global Library management. Reporting to the Sr. Manager, Clinical Systems and Analytical Reporting (CSAR), the incumbent will coordinate closely with Lead Data Managers to ensure the adoption and adherence to Data Element Standards (DES). This includes maintaining standard Case Report Forms (CRFs), edit checks, and leveraging tools such as RAVE CDMS and Veeva.
The manager will also contribute to system transformation projects, integrating their expertise into project management, technical design, and change management across global teams.
Key Responsibilities:
Provide Global Library support and review at the study level.
Coordinate with Lead Data Managers to ensure DES compliance and optimal clinical database setup.
Design and maintain CRFs and edit checks in CDMS platforms like RAVE.
Maintain Global Standard Libraries and ensure alignment with evolving clinical and regulatory requirements.
Act as a technical SME for clinical trial technologies and systems deliverables.
Support clinical trial platforms and generate analytical insights as a data scientist.
Participate in internal/external audits, respond to findings, and ensure regulatory compliance.
Develop and revise SOPs, work instructions, and business processes.
Contribute to training, vendor oversight, and cross-functional process improvements.
Basic Qualifications:
One of the following education/experience combinations is required:
Master’s degree in life sciences, computer science, or business administration with 4–6 years of relevant experience
Bachelor’s degree with 6–8 years of relevant experience
Diploma with 10–12 years of relevant experience
Preferred Qualifications:
Advanced degree (MS/PhD) in life sciences, statistics, informatics, or related discipline
Experience in pharmaceutical/biotech industry with focus on data management and clinical systems
Knowledge of Good Clinical Practice (GCP) and regulatory environments
Experience in managing clinical systems, e.g., Medidata Rave, Veeva EDC
Strong understanding of CDISC, SDTM standards, and clinical programming languages
Vendor oversight and project management skills
Familiarity with system development lifecycle and quality frameworks
Experience supporting regulatory filings and inspections
Core Competencies:
Strong analytical and problem-solving skills
Technical acumen in clinical systems and programming
Process improvement and project planning abilities
Excellent verbal and written communication
High attention to detail and quality standards
Ability to work collaboratively across global, cross-functional teams
What You Can Expect From Amgen:
Competitive base salary and comprehensive Total Rewards Plan
A collaborative, growth-focused, science-driven work environment
Development opportunities and support for long-term career advancement
Inclusive culture valuing diverse perspectives and contributions
Apply Now:
https://careers.amgen.com/job/R-213937/manager-csar-global-library-hyderabad-india
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