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.
Responsibilities
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
Requirements
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
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