Job Title: Manager, CSAR – Custom Function Programming
Location: India – Hyderabad (On Site)
Job ID: R-211537
Date Posted: March 28, 2025
Category: Clinical
Company: Amgen
Job Summary
Amgen is hiring a Manager – Custom Function Programmer within the Clinical Systems and Analytical Reporting (CSAR) team. This role focuses on the design and programming of clinical study databases, including advanced custom function development in EDC platforms such as Rave or Veeva. It involves working collaboratively with cross-functional teams, driving high-quality data collection standards, and improving systems through innovation and leadership.
Key Responsibilities
Build and program clinical studies using EDC technologies.
Act as a technical point of contact for system deliverables across programs.
Provide custom function programming and edit check development.
Collaborate with Clinical Study Teams and other departments to deliver technical support.
Ensure compliance with GCP, regulatory standards, and Amgen SOPs.
Support decision-making with data insights and programming expertise.
Recommend or implement new tools or enhancements for platform efficiency.
Support audits and regulatory inspections through documentation and technical readiness.
Develop, review, and maintain SOPs and process documentation.
Required Knowledge & Skills
Strong experience in:
Custom function programming
EDC systems (e.g., Rave, Veeva)
Clinical trial platforms and databases
GCP and regulatory compliance
Problem-solving and analytical thinking
Knowledge of:
Data management and quality risk analysis
Project planning and cross-functional collaboration
Clinical trials and drug development lifecycle
Programming languages relevant to EDC customization
Basic Qualifications
Bachelor’s degree (or equivalent) in life sciences, computer science, business, or related discipline.
Clinical research experience in biotech, pharma, or CROs.
Preferred Qualifications
Advanced degree in a related field.
9–13 years of experience in data management/programming.
Experience with vendor oversight (e.g., CROs, labs, IRT vendors).
Proven experience with clinical systems development, project management, and global team collaboration.
Why Join Amgen
Competitive total rewards package
Supportive, science-driven, and inclusive culture
Career growth opportunities in a global biotech leader
How to Apply
Apply online at: careers.amgen.com
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