Job Title:
Manager, CSAR - Study Design and 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-211494
Job Summary:
Amgen is hiring a Manager, CSAR - Study Design and Programming, responsible for building and programming clinical studies in Amgen’s trial database in accordance with established standards. Reporting to the Sr. Manager of Clinical Systems and Analytical Reporting, this role plays a critical part in ensuring quality and efficiency in the delivery of electronic data capture (EDC) technologies across global clinical programs.
Key Responsibilities:
Serve as Study Designer and Edit Check Programmer within clinical systems.
Partner with CSAR Operations and cross-functional teams to deliver EDC system support.
Act as the technical point of contact for system deliverables in assigned clinical programs.
Support decision-making as a data scientist, identifying patterns and providing analytical insights.
Ensure efficient, compliant use of EDC systems (e.g., Medidata Rave, Veeva EDC).
Provide programming support to clinical study teams and deliver database builds.
Recommend and implement system enhancements, tools, and technologies.
Contribute to the development of SOPs, policies, and associated documentation.
Support internal and external audits with proper documentation and responses.
Collaborate globally on cross-functional and matrixed teams for system and study support.
Knowledge & Experience Requirements:
Good Clinical Practice (GCP)
Performance management and analytical thinking
Clinical trial processes and data management
Study build and edit check development
Clinical databases and applications
Familiarity with programming languages
Project planning and management
Quality management and risk analysis
Regulatory compliance and inspection readiness
Understanding of process improvement methodologies
System development lifecycle (SDLC)
Basic Qualifications:
Bachelor’s degree or equivalent in life science, computer science, business administration, or related discipline.
Specialist knowledge in life sciences or a medically related field.
Experience working on clinical trials in biotech, pharmaceutical, or CRO environments.
Preferred Qualifications:
Advanced degree in a relevant field (life sciences, math, stats, CS, etc.)
Broad knowledge in clinical data management and programming.
Experience in project planning and vendor oversight (CROs, central labs, IRT, etc.)
Exposure to pharmaceutical/biotech clinical systems and reporting tools.
Soft Skills:
Strong leadership and stakeholder influence
Excellent collaboration and communication
High attention to detail and problem-solving capabilities
Strategic thinking and adaptability
Ability to manage timelines and regulatory documentation
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer and considers all qualified applicants without regard to race, religion, gender, disability, veteran status, or other legally protected characteristics. Reasonable accommodations are provided as needed.
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