Study Delivery Associate – Hyderabad, India
Company: Amgen
Location: Hyderabad, India (On-Site)
Employment Type: Full-Time, Permanent
Job ID: R-232851
Category: Clinical Research / Study Operations
Posted: 18 December 2025
About Amgen
Amgen is a global biotechnology leader committed to tackling the world’s toughest diseases. With more than 40 years of innovation, Amgen discovers, develops, manufactures, and delivers life-changing therapies that improve the health and quality of life of millions of patients worldwide. By combining advanced biology with cutting-edge technology, Amgen continues to push the boundaries of science and medicine.
Role Overview
The Study Delivery Associate provides critical administrative and operational support to clinical trial management activities. This role supports the Study Delivery Team in ensuring study timelines are met, regulatory compliance is maintained, and standardized processes are executed efficiently. The position includes responsibilities in study coordination, data management, documentation, vendor support, and operational excellence.
This role is ideal for candidates with clinical trial experience in biotech, pharmaceutical, or CRO settings, who are highly organized, detail-oriented, and adept at supporting global studies.
Key Responsibilities
Study Coordination
Maintain study-level trackers, dashboards, and timelines, ensuring timely updates
Communicate study progress, deliverables, and milestones to Study Delivery Manager
Support risk mitigation, quality reviews, and inspection-readiness activities
Assist with global site communications, logistics for investigator meetings, and trial-related events
Support study start-up activities, including system setup, supplier access, and ICF tracking
Coordinate vendor management, site engagement strategies, and investigational product logistics
Data & Systems Management
Maintain clinical trial systems (e.g., CTMS, eTMF, study training), ensuring accurate and timely data entry
Support system access requests, document management, and regulatory compliance
Documentation & Regulatory Support
Assist with preparation, review, and filing of study documents, including monitoring plans and regulatory submissions
Ensure trial master file (TMF) filing is complete, accurate, and inspection-ready
Support document version control and regulatory submission readiness
Process Improvement & Knowledge Sharing
Contribute to process improvement initiatives and share best practices across the Study Delivery Team
Provide support for operational efficiencies and global study execution
Education & Experience
Basic Qualifications:
Bachelor’s degree OR
Associate’s degree with 4 years of clinical execution experience OR
High school diploma / GED with 6 years of clinical execution experience
Preferred Qualifications:
Minimum 2 years’ experience in life sciences, biotechnology, or pharmaceutical clinical research
Experience supporting global clinical trials in biotech, pharmaceutical, or CRO environments
Proficiency with CTMS, eTMF, EDC, and Microsoft Office (Word, Excel, PowerPoint)
Knowledge of clinical trial operations, protocol adherence, regulatory compliance, and investigator documentation
Competencies & Skills
Strong understanding of clinical trial processes and study oversight
Excellent organizational, communication, and problem-solving skills
Ability to manage accurate data flow, maintain inspection-ready documentation, and support compliance
Skilled in coordinating multiple tasks and collaborating across global teams
Culturally sensitive, adaptable, and able to work in a fast-paced environment
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Reasonable accommodations are provided to individuals with disabilities to support the application process, essential job functions, and benefits of employment.
Why Join Amgen
Be part of a leading biotechnology organization driving innovation in life sciences
Contribute to global clinical research projects that improve patient outcomes
Collaborate with diverse, cross-functional teams across multiple therapeutic areas
Access opportunities for professional growth, training, and development in clinical operations
Apply Now
Advance your career as a Study Delivery Associate at Amgen and play a vital role in supporting clinical trial execution, regulatory compliance, and global study delivery excellence.
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