Note: The job is a remote job and is open to candidates in USA. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. The Adjudication Project Manager is primarily responsible for managing all endpoint adjudication processes for a clinical trial, ensuring adherence to regulations and delivering projects within budget and timelines.
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
- 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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