Note: The job is a remote job and is open to candidates in USA. ICON plc is a healthcare intelligence and clinical research organization. The company is seeking an Adjudication Project Manager to manage endpoint adjudication processes for clinical trials, including project timelines, budgets, documentation, workflows, client communications, and quality control.
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 endpoint adjudication processing team
- Develops and monitors 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
Skills
- 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
- Endpoint adjudication experience preferred
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
- United States (Remote)
Company Overview
Company H1B Sponsorship