Amy Olson Miller

About Amy Olson Miller

Results‑driven clinical research leader with a diverse background spanning academic medicine and CRO environments. Known for driving cross‑functional teams toward best‑in‑class operational improvements through strong communication, analytical thinking, and practical problem‑solving. Equally effective as an independent contributor or collaborative team leader, with a proven ability to manage competing priorities and deliver on critical business objectives.Brings strong learning agility, relationship‑building skills, and a track record of strengthening site and vendor partnerships. Experienced in process improvement, organizational change management, and leading teams through complex operational challenges. Recognized for excellence in legacy study cleanup, TMF remediation, and document reconciliation to ensure inspection‑ready quality.

Experience

1. Clinical Team Manager

   ICON plc

   Aug 2022 — Present

   Develops and contributes to key study oversight materials, including the Clinical Monitoring Plan, monitoring tools, visit report templates, and training resources for clinical research associates (CRAs). Leads CRA training for assigned studies and ensures ongoing compliance with all study‑specific training requirements.Oversees protocol deviations and follow‑up actions to assess compliance, identify trends, and escalate issues appropriately. Participates in the development of corrective and preventive actions to support continuous quality improvement. Reviews clinical data—including electronic case report forms and central laboratory outputs—to ensure site‑level data quality, integrity, and timely communication with study teams and sponsor leadership.Ensures CRAs maintain inspection‑ready sites and Trial Master File (TMF) documentation at all times. Facilitates regular meetings with study teams, clinical sites, and individual CRAs to share updates, reinforce best practices, and drive consistency and efficiency across monitoring activities.Performs site qualification, initiation, interim monitoring, and close‑out visit support as needed based on study requirements.

Education

• University of Notre Dame - Mendoza College of Business

  MS, Non-Profit/Public/Organizational Management

  2006

• Indiana University South Bend

  BA, Political Science and Education