Whether your project is a Phase II-III clinical trial, post-market study, development of case report forms, medical writing, or statistical analysis, each will require successful project management with quantified expectations and clear communications. PMI’s Scope of Work defines PMI and client responsibilities for implementing your project, and a Project Manager is assigned the responsibility for communicating those expectations. He or she also fulfills the role of your key contact throughout the life of your project.

With an average of 21 years in clinical study management, PMI project managers have a background in clinical research requirements, strong analytical abilities, and refined communication skills. Each project manager heads the entire PMI team with an eye on accountability and continuity. At program initiation, he or she conducts a team launch meeting to review the Scope of Work and discuss any questions that arise. The project manager continues to oversee the activities of the project team over the life of your project.

These important staff members are supported with formal budget and schedule tracking systems, weekly executive staff meetings to review project performance and issues, work templates developed from regulatory guidance and previous experiences, and a staffing registry to facilitate identification of specialists as needed.

Our Project Management and Administration Services includes:

Project Set-up/Initiation Activities

  • Review of scope of work
  • Review of budget
  • Review of resources and responsibilities
  • Review of contract
  • Conduct project initiation meeting with client
  • Identify project risk factors
  • Define key communication preferences, frequency and tools
  • Set up study using management tracking software – Time, Resource and Budget
  • Set up electronic file management system
  • Develop project plans relevant to scope of work
  • Conduct project team training

Ongoing Project Activities

  • Perform tasks to achieve milestones as identified in project scope of work
  • Maintain ongoing communication with client
  • Manage and meet regularly with PMI project team
  • Oversee site management activities
  • Anticipate and solve project issues
  • Review risk factors and develop contingency plans
  • Review and approve invoices and expense reports
  • Actively review and communicate project timelines, finance and resource status
  • Review, approve and disseminate key reports
  • Report project status to PMI executive committee
  • Participate in client meetings
  • Maintain adherence to Quality Management System (training, project plans, etc.)
  • Review project team performance and training needs
  • Maintain and update project management tracking systems
  • Communicate and document scope of work changes

Close-Out/Completion Project Activities

  • Confirm project deliverables are completed and provided to client
  • Confirm performance of site close out activities
  • Finalize and approve invoices and expense reports
  • Return project property to client
  • Conduct Quality Management System project completion audit