Study Delivery Senior Associate

Responsibilities

• Provide global study management support to clinical study teams to ensure timely and compliant execution
• Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools
• Coordinate logistics for investigator meetings, trial events, and site communications
• Manage assigned start-up activities, including system setup, access management, and document readiness
• Monitor global enrollment, data flow, and quality indicators using study dashboards
• Track and report study progress while coordinating with vendors to resolve operational issues
• Maintain and monitor clinical trial systems such as CTMS to ensure accurate data entry
• Manage trial documentation (e.g., TMF) to ensure inspection readiness
• Support audit and inspection processes, including Corrective and Preventive Actions (CAPA)

Requirements

• Master's degree OR Bachelor's degree + 2 years of clinical execution experience OR Associate's degree + 6 years OR High school diploma + 8 years
• Experience in life sciences or a medically related field
• Proficiency in CTMS, eTMF, EDC, and MS Office tools
• Strong collaborative and communication skills within a team environment

Preferred Qualifications

• 3 years of work experience in life sciences, including 1 year of biopharmaceutical clinical research experience
• Experience working on global clinical trials
• Experience overseeing vendors and suppliers
• Experience with risk-based site monitoring and CAPA implementation

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, manufacture, and deliver innovative medicines to help millions of patients worldwide.