.You will need to login before you can apply for a job.Project Manager, IDEA - Remote, USICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Position Summary:This position is primarily responsible for managing all Data Monitoring Committee (DMC) and/or endpoint adjudication processes for a clinical trial.Job Functions/Responsibilities:
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 35%) domestic and/or international.
- Manages project in a timely manner in adherence with ICON's SOP's, ICH, GCP and appropriate regulation and liaise with other departments as necessary.
- Delivers projects in accordance with the contract, timelines and study budget
- Identifies out of scope activities and initiates budget change orders and contract amendments
- Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings
- Facilitates the electronic endpoint adjudication system for the endpoint adjudication project
- Ensures all necessary study specific training is provided to study team to improve performance and knowledge. Provides coaching I mentoring as necessary.
- 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)
- Performs user acceptance testing of electronic endpoint adjudication system
- Performs data reconciliation
- Serves as the primary study contact for client and internal and external study teams.
- Leads internal and external study team meetings.
- Leads internal DMC and endpoint adjudication processing team.
- Develops and monitors DMC and endpoint adjudication processing workflows to maintain efficiency
- Prepares meeting agenda and facilitates the completion and distribution of meeting minutes
- Facilitates the development of project reports. Generates and distributes project reports to the study team.
- Coordinates DMC and Endpoint Adjudication
- Committee members and data review/adjudication process
- Conducts project/system specific training to committee members
- Implements Quality Control measures for adjudication process and adjudication outcomes as necessary
- Performs project finance reporting activities
- Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues