Adjudication Project Manager I

Adjudication Project Manager I

Requirements

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

Responsibilities

• Manages project(s) in a timely manner in adherence with ICON’s SOP’s, ICH-GCP, and appropriate regulations
• Delivers projects in accordance with the contract, timelines, and study budget
• Identifies out of scope activities and initiates budget change orders and contract amendments
• Performs project finance reporting activities
• Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings
• Performs user acceptance testing of electronic endpoint adjudication system
• Ensures all necessary study specific training is provided to study team to improve performance and knowledge
• Develops and maintains all trial documentation (i.e. Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)
• Serves as the primary study contact for client and internal and external study teams
• Leads internal DMC and endpoint adjudication processing team
• Develops and monitors DMC and endpoint adjudication processing workflows to maintain efficiency
• Facilitates the development of project reports and distributes reports to the study team
• Implements Quality Control measures for adjudication process and adjudication outcomes as necessary

Preferred Qualifications

• Endpoint adjudication experience preferred