Amanda S.

About Amanda S.

Experienced Clinical Research Professional with a demonstrated history of working in the hospital, health care, & pharmaceutical industry. Multifaceted experience in Phase I-IV global clinical trials with disease experience in oncology, rare diseases, gene therapy, and pediatrics.

Experience

1. Senior Clinical Operations Lead

   Sarepta Therapeutics

   Mar 2025 — Present

   Senior Clinical Operations Lead and trial manager for global gene therapy and RNA therapy clinical trials, responsible for all facets of study and site start-up and activation, study and vendor management, and general oversight and escalation. In this role I manage a cross-functional team and am responsible for oversight and management of CROs and third party vendors. I work with department leadership to establish study metrics and timelines consistent with company goals and ensure accurate tracking and reporting of study progress. Additionally, I am responsible for management and oversight of study and vendor contracts and budgets, have experience creating, reviewing, and/or contributing core study documents like protocols, IBs, consent and assent forms, and study plans and manuals, and consistently ensure inspection-readiness of the study and TMF.Additionally, I have led and participated in numerous department-level and cross-functional process improvement initiatives and am a core team member of an Employee Resource Group. Through this role and my previous roles at Sarepta, I have also gained experience in line management and peer mentorship.

Education

• University of Wisconsin-Madison

  Bachelor’s Degree, Neurobiology and Neurosciences

  2011 — 2015

• Boston University

  Master of Science - MS, Clinical Research

  2018 — 2020