This role supports global clinical trial execution as a Study Delivery Senior Associate at Amgen's Hyderabad office. The position manages study planning, enrollment tracking, vendor coordination, and regulatory compliance across assigned trials. The associate works with study teams to oversee startup activities, monitor trial progress, and escalate risks while identifying process improvements.
Responsibilities
Develop and maintain study trackers, dashboards, timelines, and vendor management tools for visibility
Monitor global enrollment, data flow, and quality indicators; take proactive action on deviations
Lead assigned risk management activities and coordinate issue resolution across study teams
Manage start-up activities including system setup, access, and document readiness
Escalate risks and early warning signals with proposed solutions to stakeholders
Requirements
Master's degree, or Bachelor's degree with 2 years clinical execution experience
3 years life sciences or medically related work experience preferred
1 year biopharmaceutical clinical research experience in biotech, pharma, or CRO
Strong proficiency with MS Office, CTMS, eTMF, and EDC systems
Expertise in clinical trial processes, risk monitoring, and regulatory compliance
Experience overseeing vendors and executing site monitoring activities
Excellent communication, documentation accuracy, and cross-functional collaboration skills
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