Study Delivery Sr Associate

Responsibilities

• Support the setup and maintenance of study-level trackers, dashboards, and timelines
• Communicate study progress, timelines, and deliverables to the Study Delivery Manager
• Assist with tracking study actions, risk mitigation, and the preparation of quality reviews
• Ensure completion of study team training and inspection readiness to maintain regulatory compliance
• Support study start-up activities, including system setup, supplier access, 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 and study training with accurate data entry
• Assist with preparing, reviewing, and maintaining study documentation and TMF filing

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
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Working knowledge of CTMS, eTMF, and EDC systems
• Experience with tracking and filing essential documents like protocols and informed consent forms
• Ability to maintain accurate data entry and manage clinical trial data flow

Preferred Qualifications

• 2 years of work experience in a life sciences or medically related field
• 1 year of biopharmaceutical clinical research experience in 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. A biotechnology pioneer since 1980, Amgen discovers, develops, manufactures, and delivers innovative medicines to help millions of patients worldwide.