Study Delivery Sr Associate
Amgen · Hyderabad, India
Clinical OperationsFull-timeCompany career page
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Role summary
Amgen seeks a Study Delivery Senior Associate to provide clinical study management support in Hyderabad, India. The role involves coordinating study planning, monitoring execution, managing vendors and systems, and ensuring compliance throughout the clinical trial lifecycle.
What they're looking for
- Master's degree OR Bachelor's degree with 2 years clinical execution experience OR Associate's degree with 6 years experience OR High school diploma with 8 years experience
- 3 years life sciences or medically related work experience, including 1 year biopharmaceutical clinical research in biotech, pharma, or CRO
- Proficiency in CTMS, eTMF, EDC systems and Microsoft Office tools
- Strong documentation accuracy, data tracking, and regulatory compliance knowledge
- Experience with risk-based monitoring, audit/inspection processes, and CAPA implementation
- Vendor oversight and global clinical trial experience
- Excellent collaborative communication and cross-functional team engagement skills
What you'll be doing
- Develop and maintain study trackers, dashboards, timelines, and vendor management tools for visibility and accuracy
- Monitor global enrollment, data flow, and quality metrics using dashboards; address deviations and risks proactively
- Coordinate logistics for investigator meetings, site communications, and recruitment/retention strategy delivery
- Manage clinical trial systems data entry, documentation oversight, and TMF maintenance for inspection readiness
- Identify, escalate, and resolve operational issues; support audit and CAPA processes across studies
Privacy & handoff
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