Study Delivery Sr Associate

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 escalate 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.

Strong collaborative and effective communication skills within a team environment.

Understands importance of accuracy in documentation, data tracking, and compliance checks. Identifies discrepancies and escalates appropriately.

Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments

Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support

Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools. Ability to maintain accurate and timely data entry. Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance

Experience with overseeing vendors and suppliers

Experience executing risk-based site monitoring, Audit and Inspections Corrective and Preventive Actions (CAPA) implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness

Cultural sensitivity and collaboration across global teams.

Ability to recognize, highlight and resolve issues. Demonstrates curiosity and willingness to take on new tasks.

Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles

Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents are version-controlled and inspection-ready.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.