Clinical Start-up Unit (CSU)
Monitoring Resources

Project Management

TRIO’s group of talented and experienced project managers have significant expertise running oncology trials—including registration trials. Their skills are further enhanced with internal training on clinical trial management methodology as well as on the science of the disease and the treatments through medical education courses and highlights of the major annual oncology conferences. Each of our Project Managers is extremely passionate about oncology research, which translates into a low turnover rate within the team and on every project run by TRIO.

Among their main responsibilities, TRIO Project Management:

  • Defines and plans study activities, metrics and timelines and ensures those are met while maintaining quality throughout the duration of the trial
  • Acts as the link to the sponsor to ensure clear, concise communication and on-time performance
  • Leads the multidisciplinary operational team involved in each project and oversees every aspect of clinical trial management, handling changes and new objectives as they arise
  • Leads the development of study documents (i.e. Case Report Form (CRF), Informed Consent Form (ICF), Clinical Study Report (CSR)) and plans and guidelines (i.e. operational plan, communication plan, training plan, monitoring plan, data validation plan, deviation management guidelines and drug management guideline) in order to guarantee that the study is conducted adequately
  • Selects vendors as needed and oversees the activities contracted to these vendors
  • Trains the different team members of the project
  • Ensures careful site management and daily support to Clinical Research Associates (CRAs) and sites when questions arise
  • Ensures adequate data quality prior to each analysis

Global systems, processes, tools and reports enable the project managers to anticipate the next steps in the study process and helps them to proactively manage issues. TRIO Project Managers always demonstrate flexibility, willingness to meet sponsor needs/new requests and innovation. They are a key component of TRIO’s efficient operations.

The TRIO Project Management team is composed of:

  • The Director
  • Global Project Coordinators (who oversee several projects)
  • Senior Study Managers (who are the lead on a given project)
  • Study Managers (who perform site management activities and are located in Edmonton, Paris or Montevideo in order to facilitate the interactions with the sites and the CRAs)
  • Data Validation Specialists (who perform the clinical review of the data)
  • Administrative Project Coordinators (who assist the project team with administrative aspects and also ensure completeness of the Trial Master File)
  • General Administrative Clerks (who maintain electronic TMF)