Manager, CSAR – Study Design and Programming
Location: India – Hyderabad
Work Type: On-Site
Job ID: R-214445
Date Posted: April 30, 2025
About Amgen:
At Amgen, we believe you're part of something bigger. Since 1980, we've led the biotechnology sector, advancing care across Oncology, Inflammation, General Medicine, and Rare Diseases. Our goal is to deliver innovative medicines that improve lives. Join us in our mission to serve patients with serious illnesses and contribute to a collaborative, innovative, and science-based culture.
Position Summary:
We are seeking a Manager, CSAR – Study Design and Programming to join our Clinical Systems and Analytical Reporting team. Reporting to the Sr. Manager, the selected candidate will lead and contribute to the development and programming of studies in our clinical trial database, ensuring compliance with Amgen’s standards, procedures, and best practices. The role requires a strategic leader who can influence stakeholders, work cross-functionally, and ensure high-quality deliverables using electronic data capture (EDC) technologies.
Key Responsibilities:
Support clinical trial platform technologies and act as a data scientist by uncovering insights through patterns and analytics.
Coordinate and provide programming support to clinical study teams.
Ensure consistent and compliant use of EDC systems (e.g., Rave EDC, Veeva EDC).
Serve as the technical point of contact for system deliverables across defined programs.
Recommend and implement system enhancements and new tools to streamline development cycles.
Contribute technical and process expertise to the evaluation of emerging technologies.
Develop, review, and implement policies, SOPs, and supporting documentation.
Ensure documentation aligns with CSAR operational, regulatory, and technical processes.
Assist in audit readiness and response to internal/external audit findings.
Required Knowledge & Skills:
Good Clinical Practice (GCP)
Strong performance management and analytical thinking capabilities
Understanding of drug development and clinical trial processes
Proficient in data management and clinical trial databases
Expertise in study build and edit check programming
Familiarity with relevant programming languages
Knowledge of systems development lifecycle
Project planning and risk management experience
Familiarity with regulatory filings and inspection processes
Experience collaborating in global, cross-functional environments
Basic Qualifications:
Bachelor’s degree or equivalent in life sciences, computer science, business administration, or related discipline
Specialized knowledge or experience in life sciences or medical research
Clinical research experience within biotech, pharma, or CRO settings
Preferred Qualifications:
Advanced degree (Master’s or PhD) in life science, computer science, math, statistics, or related field
9+ years of experience in data management/programming in biotech or pharma
Project planning/management experience
Experience in vendor oversight (e.g., CROs, central labs, IRT vendors)
Estimated Salary: ₹35–50 LPA, based on experience and skillset
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