Study Delivery Sr Associate

Responsibilities

• Support study coordination by maintaining trackers, dashboards, and timelines
• Communicate study progress and deliverables to the Study Delivery Manager
• Assist with study start-up activities, including system setup and document readiness
• Manage shipment, reconciliation, and analysis of biological samples
• Coordinate investigational product logistics and ensure compliance with reconciliation processes
• Maintain clinical trial systems such as CTMS, ensuring timely and accurate data entry
• Assist with preparing and reviewing study documentation, including regulatory submissions and monitoring plans
• Support TMF filing and document management to ensure inspection readiness

Requirements

• 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
• Experience in life sciences or biopharmaceutical clinical research
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Working knowledge of CTMS, eTMF, and EDC systems
• Ability to manage clinical trial data flow and maintain regulatory compliance

Preferred Qualifications

• 2 years of work experience in a life sciences or medically related field
• 1 year of biopharmaceutical clinical research experience within a biotech, pharmaceutical, or CRO company
• Experience working on global clinical trials

About the Company

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases. As a biotechnology pioneer, we discover, develop, and deliver innovative medicines to help millions of patients worldwide.