Job Title: Manager, CSAR – Study Design and Programming
Location: India – Hyderabad (On Site)
Job ID: R-211494
Date Posted: March 28, 2025
Category: Clinical
Company: Amgen
Job Summary
Amgen is seeking a Manager – Study Designer and Edit Check Programmer within the Clinical Systems and Analytical Reporting (CSAR) team. This role involves building and programming clinical trial studies in EDC systems, supporting study teams, ensuring data quality and compliance, and contributing to technical innovation across systems. It requires cross-functional collaboration, technical leadership, and strong programming knowledge, especially in tools like Rave EDC and Veeva EDC.
Key Responsibilities
Support and optimize use of clinical trial platform technologies.
Program and design clinical trial databases in compliance with Amgen standards.
Act as a data scientist to deliver insights and identify patterns.
Provide programming support to Clinical Study Teams.
Lead or coordinate study builds and edit check development.
Serve as a technical contact for system deliverables and innovation.
Recommend and implement tools and process improvements.
Ensure complete and regulatory-compliant documentation.
Contribute to audit readiness and response efforts.
Collaborate with cross-functional and global teams.
Qualifications
Basic Qualifications
Bachelor’s degree (or equivalent) in life sciences, computer science, business administration, or related discipline.
Relevant experience in clinical research, data management, or systems support in a pharmaceutical, biotech, or CRO environment.
Preferred Qualifications
Advanced degree in a related field with 9–13 years of experience.
Broad experience in clinical data programming and study design in the Pharma/Biotech sector.
Experience managing vendors (CROs, central labs, IRT, imaging).
Familiarity with:
GCP, drug development, and trial processes
Performance measurement and problem-solving methodologies
EDC systems (Rave, Veeva), edit check programming, and system lifecycles
Regulatory documentation, audits, and SOPs
Risk analysis, project planning, and process improvement
What Amgen Offers
Competitive salary and total rewards
Supportive environment for professional growth
Opportunity to contribute to impactful clinical programs in a global biotech leader
How to Apply
Visit: careers.amgen.com
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