Study Delivery Sr Associate

Responsibilities

• Support study setup and maintenance of trackers, dashboards, and timelines
• Communicate study progress and deliverables to the Study Delivery Manager
• Assist with tracking study actions, risk mitigation, and quality reviews
• Ensure study team training and inspection readiness for regulatory compliance
• Support study start-up activities, including system setup and document readiness
• Manage shipment, reconciliation, and analysis of biological samples
• Coordinate investigational product logistics and vendor relationships
• Maintain clinical trial systems such as CTMS and eTMF with accurate data entry
• Assist with preparing and reviewing study documentation and regulatory submissions
• Support TMF filing and process improvement initiatives

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
• Working knowledge of CTMS, eTMF, and EDC
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Experience with tracking and filing essential documents like protocols and ICFs
• Ability to collaborate effectively across global teams

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 environment
• 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.