Adjudication Project Manager

ICON plc•Blue Bell, SD
•Remote

About The Position

The Adjudication Project Manager joins ICON’s Full Service Independent DMC and Endpoint Adjudication (IDEA) team and is primarily responsible for managing all endpoint adjudication processes for a clinical trial. The role manages projects in accordance with ICON’s SOPs, ICH-GCP, applicable regulations, contract terms, timelines, and study budgets. It serves as the primary study contact for clients and internal and external study teams, and leads the internal endpoint adjudication processing team. The position develops and maintains trial documentation, training, workflows, reports, and quality control measures to support efficient and reliable adjudication processes. It also manages project financial reporting and scope changes, participates in client and investigator meetings, and performs user acceptance testing of the electronic endpoint adjudication system. The role is remote in the United States.

Requirements

  • Two years of project management experience in clinical research.
  • Experience with timeline and budget management.
  • Strong written and verbal communication skills.
  • Time management skills and the ability to prioritize efficiently.
  • Detail-oriented.
  • Bachelor’s degree.

Nice To Haves

  • Endpoint adjudication experience.

Responsibilities

  • Manage projects in a timely manner in adherence with ICON’s SOPs, ICH-GCP, and applicable regulations.
  • Deliver projects in accordance with the contract, timelines, and study budget.
  • Identify out-of-scope activities and initiate budget change orders and contract amendments.
  • Perform project finance reporting activities.
  • Attend and present at Investigator Meetings, Client Kick-Off Meetings, and other client meetings.
  • Perform user acceptance testing of the electronic endpoint adjudication system.
  • Ensure necessary study-specific training is provided to the study team.
  • Develop and maintain trial documentation, including the Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual.
  • Serve as the primary study contact for the client and internal and external study teams.
  • Lead the internal endpoint adjudication processing team.
  • Develop and monitor endpoint adjudication processing workflows to maintain efficiency.
  • Facilitate the development of project reports and distribute them to the study team.
  • Implement quality control measures for the adjudication process and outcomes as necessary.

Benefits

  • Competitive base salary and performance-related incentives.
  • Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Employee assistance programmes and wellbeing resources.
  • Learning and development opportunities through structured training and career pathways.
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