Study Delivery Senior Associate

About the role

Study Delivery Senior Associate at Amgen supports global clinical study teams by managing study-level trackers, dashboards, timelines, and tools such as vendor management, sample tracking, and drug supply planning. The role coordinates logistics for investigator meetings, trial events, and site communications, and oversees start‑up activities including system setup, access management, and document readiness. Using CTMS, eTMF, and EDC systems, the associate monitors enrollment, data flow, and quality indicators, proactively addressing deviations and risks. Responsibilities include risk and quality management, recruitment and retention strategy delivery, study training oversight, and vendor/supplier set‑up. The associate maintains trial documentation (TMF) for inspection readiness, supports audit and CAPA processes, and contributes to best‑practice development and process improvement. Candidates should have a Master’s or Bachelor’s degree with clinical execution experience, strong collaboration and communication skills, expertise in clinical trial operations, proficiency with MS Office and clinical trial systems, and experience with global clinical trials and risk‑based monitoring.

What you’ll do

• Lead development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility.
• Coordinate logistics for investigator meetings, trial events, and site communications.
• Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards.
• Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks.
• Lead delivery of assigned risk and quality management activities.
• Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance.
• Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.
• Manage Study Training system activities and oversight.
• Build and maintain effective relationships with internal study team members, vendors and investigator sites.
• Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned.
• Identify, prioritize, and elevate risks effectively to support swift, informed decisions.
• Lead vendors and supplier set-up to ensure quality, speed, and consistency in deliverables.
• Maintain and monitor clinical trial systems (e.g., CTMS), ensuring accurate and timely data entry and reporting.
• Support data collection oversight, including query resolution and reconciliation activities.
• Manage trial documentation (e.g., TMF) to ensure inspection readiness.
• Contribute to best practice development, knowledge-sharing and process improvement within the study support community.
• Proactively identify and highlight opportunities to streamline / automate activities within remit.
• Support Audit/Inspections including Corrective and Preventive Actions (CAPA) processes and embed lessons learned across studies.

What you’ll bring

• Master’s degree OR
• Bachelor’s degree and 2 years of clinical execution experience OR
• Associate’s degree and 6 years of clinical execution experience OR
• High school diploma / GED and 8 years of clinical execution experience

Nice to have

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

Skills