Study Delivery Sr Associate
Amgen · Hyderabad, India
Clinical OperationsFull-timeCompany career page
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Role summary
This senior associate role supports clinical study teams in global study management, focusing on planning, coordination, and execution across the study lifecycle. Responsibilities include managing study tools and dashboards, monitoring enrollment and data quality, coordinating with sites and vendors, and ensuring regulatory compliance throughout trial operations.
What they're looking for
- Bachelor's degree and 2 years clinical execution experience, or equivalent combination
- Working knowledge of CTMS, eTMF, EDC systems and Microsoft Office
- Proficiency with clinical trial processes in biotech, pharmaceutical, or CRO settings
- Strong documentation accuracy, data tracking, and compliance verification skills
- Experience managing vendor oversight and risk-based monitoring activities
- Effective cross-functional communication and stakeholder engagement abilities
- Understanding of drug development and clinical trial execution principles
What you'll be doing
- Develop and maintain study trackers, dashboards, timelines, and vendor management tools
- Monitor global enrollment, data flow, and quality metrics to identify and address deviations
- Coordinate study start-up activities including system setup and document readiness verification
- Manage clinical trial systems data entry, query resolution, and trial master file documentation
- Identify, escalate, and support resolution of study risks and operational issues
Privacy & handoff
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