Job Title: Manager, CSAR – Custom Function Programming
Department: Clinical
Company: Amgen
Location: Hyderabad, India
Work Location Type: On Site
Date Posted: March 28, 2025
Application Deadline: Not specified
Job ID: R-211537
Job Summary:
Amgen is seeking a Manager, CSAR – Custom Function Programming, a key role supporting electronic data capture (EDC) systems in clinical trials. The individual will act as a Study Designer and Edit Check Programmer, ensuring high-quality deliverables in compliance with Amgen standards. The position requires a blend of leadership, technical programming, and clinical systems expertise to support clinical study teams and drive innovation in data-driven decision-making.
Key Responsibilities:
Design and program studies within the clinical trial database following Amgen standards.
Collaborate with CSAR Operations and cross-functional stakeholders for consistent, efficient EDC system use.
Act as a technical point of contact for system deliverables across studies and programs.
Coordinate and provide programming support to clinical study teams.
Evaluate and implement system enhancements and emerging technologies.
Develop, review, and enforce policies, SOPs, and associated documentation.
Support audits and ensure compliance with regulatory standards.
Analyze data trends and provide insights as a data scientist.
Manage project timelines and maintain comprehensive documentation for operational activities.
Knowledge Requirements:
Good Clinical Practice (GCP)
Clinical data management processes
Clinical trial databases and applications
Custom function programming and edit check development
Understanding of:
Drug development and trial lifecycle
Programming languages (unspecified, likely SAS, SQL, etc.)
Systems development lifecycle
Project planning and management
Risk analysis and quality management
Regulatory submissions and inspection readiness
Basic Qualifications:
Bachelor’s degree or equivalent in life science, computer science, business administration, or related field
Experience in life sciences or medically related field
Clinical research experience from pharmaceutical, biotech, or CRO environment
Preferred Qualifications:
Advanced degree in life sciences, statistics, computer science, or related field
Broad experience in clinical data management/programming in pharma/biotech
Experience overseeing vendors (CROs, central labs, etc.)
Exposure to process improvement methodologies and project management
Experience with EDC systems (e.g., Medidata Rave, Veeva)
Soft Skills:
Leadership and influencing skills
Strategic thinking and innovation mindset
Strong problem-solving and analytical skills
Collaborative and cross-functional team leadership
Effective written and verbal communication
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, gender, orientation, disability, or veteran status. Accommodations are available for individuals with disabilities.
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