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Senior Project Manager

2 months ago

Canada ICON Strategic Solutions Full time
Senior Project Manager - Oncology Trials

ICON Strategic Solutions is seeking a highly skilled Senior Project Manager to lead our Oncology trials. As a key member of our team, you will be responsible for the successful delivery of clinical trials, ensuring timely and within-budget completion.

Key Responsibilities:
  • Manage clinical trial teams, including establishing and leading Clinical Trial Teams (CTTs)
  • Support clinical supplies planning, including deployment and interactions with external vendors
  • Initiate planning for Investigator meetings and protocol training
  • Plan and assess protocol ancillary supplies
  • Complete trial set-up and maintain SPECTRUM
  • Schedule and prepare for Recruitment Planning Meetings for CTTs
  • Initiate recruitment/retention planning and enrollment tracking
  • Oversee protocol training activities, including IMs and CRAs training meetings
  • Ensure appropriate postings to investigative site portals
  • Responsible for operational deliverables in preparation for site ready, country allocation, and achievement of recruitment targets
  • Point of escalation for study-related operational issues
  • Responsible for operational details at Operational Reviews
  • Set up and maintain Trial Master File (eTMF)
  • Ensure alignment of budget with protocol needs
  • Responsible for executing protocol within the budget
  • Responsible for creating and maintaining ADI logs
  • Develop Site Monitoring Plan (SMP) with input from the monitoring excellence group
  • Develop study-related manuals (e.g., administrative binder, lab manuals)
  • Manage Emergency Unblinding (EUB) Call Center activities
  • Co-author newsletters with CS
  • Approve contracts, invoice payments, and change orders for vendors, as necessary
  • Responsible for end-of-study reconciliation (clinical & ancillary supplies)
  • Oversee all HQ close-out tasks
  • Responsible for ongoing monitoring of trial activities, e.g., dashboards, tracking
  • Support CS activities as needed to achieve CTT deliverables
  • Interface with External Data Coordination and Data Management
  • Responsible for quality control and inspection readiness at all times
  • Responsible for risk assessment, mitigation planning, and execution

We are looking for a highly motivated and experienced Senior Project Manager to join our team. If you have a strong background in clinical research and project management, we encourage you to apply.