Project Manager, Clinical Outcomes
ICON PLC - Warrington, FL

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Project Manager, Clinical Outcomes
Location – Warrington, PA This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The Project Manager will be responsible for the delivery of projects in accordance with the contract, timelines and study budget. Overview of the Role
  • Identification and review of change orders for the budget
  • Attend and present at client Investigator, Kick-Off and client meetings
  • Ensure all necessary study specific training is provided to study team to improve performance and knowledge. Provide coaching / mentoring as necessary.
  • Management of Electronic Case Report Forms (eCRF) development process
  • Development/ Review/ Maintenance of all trial documentation (Charter, eCRF, SRS, Reviewer Training Manuals)
  • User Acceptance Training and demonstration of eCRF
  • Data reconciliation
  • Primary client and CRO contact; develops successful working relationships with client / CRO
  • Preparation and management of meeting agendas and minutes
  • Prepare / Approve Project Reports
  • Management of Study Center(s)
  • Coordinates readers and review sessions
  • Conducts reader training with support of Project Director
  • Monitors Offsite Assessments/Blinded Reads
  • Quality Control of Offsite Assessments/Blinded Reads
  • Ensures all management/ tracking systems are up to date
  • Provide regular feedback to senior management on project status, client satisfaction and staffing issues.
  • Manages Data Management Lead for scheduling and preparation of data deliveries as required
  • Participate in Business Development activities as appropriate
  • Supports internal, client, and regulatory audits
  • Ability and willingness to travel
  • Participate in interview as required
  • Travel (approximately 35%) domestic and/or international

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