Sr. Associate Systems Analyst – Clinical Data Hub
Job ID: R-243713
Location: Hyderabad, India
Work Type: On-Site
Category: Clinical
About Amgen
Amgen is a leading biotechnology company that leverages biology and technology to develop innovative therapies for some of the world's most challenging diseases. For over 40 years, Amgen has been at the forefront of biotechnology innovation, discovering, developing, manufacturing, and delivering medicines that improve and extend the lives of millions of patients worldwide.
Through cutting-edge science, advanced technology, and human genetic data, Amgen continues to push beyond today's known boundaries to create meaningful healthcare solutions.
Position Summary
The Sr. Associate Systems Analyst – Clinical Data Hub is responsible for supporting and maintaining validated business applications and IT infrastructure within a regulated clinical environment. The role focuses on infrastructure security, system validation, software testing, release management, and quality assurance activities to ensure application reliability, compliance, performance, and security.
This position works closely with business stakeholders, software vendors, developers, business analysts, quality teams, and infrastructure teams to support system enhancements, validation activities, and application lifecycle management while ensuring compliance with GxP and other regulatory standards.
Key Responsibilities
Infrastructure & System Support
Support, monitor, and execute infrastructure security patch installations and configuration updates.
Collaborate with network and infrastructure administrators to maintain secure and reliable systems.
Ensure optimal system uptime, performance, and security.
Support maintenance activities for business-critical clinical applications.
Validation & Testing
Review software release notes and identify regression testing requirements.
Develop comprehensive test strategies, validation plans, and test cases.
Perform manual and automated testing, including:
Functional Testing
Regression Testing
Performance Testing
Non-Functional Testing
Document, track, and report defects identified during testing.
Collaborate with development teams to investigate and resolve issues.
Prepare and execute validation protocols according to GxP requirements.
Perform:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Ensure all validation procedures comply with regulatory and corporate standards.
Requirements & Quality Management
Review and advise on requirements documentation to ensure requirements are measurable and testable.
Validate that acceptance criteria and business expectations are fully addressed.
Maintain high-quality user stories and requirements within tools such as Jira.
Ensure business applications remain in a validated and compliant state.
Maintain complete documentation of:
Validation Plans
Test Cases
Test Results
Defect Reports
Validation Evidence
Release & Change Management
Analyze vendor release notes and assess business impact.
Work with Software-as-a-Service (SaaS) providers to evaluate system updates.
Support implementation and validation of application enhancements and upgrades.
Participate in Agile development and release cycles.
Cross-Functional Collaboration
Work closely with:
Business Analysts
Developers
Product Managers
Quality Teams
Application Support Teams
System and Network Administrators
Support efficient and standardized processes across teams.
Participate in project planning, estimation, and delivery activities.
Contribute to continuous process improvement initiatives.
Required Qualifications
Education
Bachelor's Degree or Master's Degree in:
Information Systems
Computer Science
Information Technology
Related Technical Discipline
Experience
5–8 years of experience in:
Information Systems Administration
Application Support
Computer System Validation
IT Quality Assurance
Clinical Systems Support
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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