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Clinical Trial Lead
Updated on 3/20/2023
Toronto, ON, Canada
Experience Level
  • Minimum of 5 years of relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
  • Minimum of three (3) year experience as a Clinical Trial Lead or equivalent (Clinical Trial/Study Manager) or relevant clinical operations experience at a CRO, biotech, or pharma company
  • In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the critical elements of success
  • Early phase clinical trial experience
  • Manage clinical operations deliverables including timeline, quality, scope, and financials
  • Work closely with the Project Manager to develop plans, monitor resource allocation and ensure that clinical site management and monitoring is being delivered per contract with quality and efficiency
  • Proactively identify risks and escalate to Project Manager and other appropriate functional leads
  • Together with the Project Manager, ensure transparent communication both internally and externally regarding study progress and issues
  • Develop and maintain project-specific clinical operations plans as required per project (e.g. Clinical Monitoring Plan, Cohort Management Plan, Recruitment Plan, etc.)
  • Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs
  • Develop training materials and conduct training for the clinical operations team throughout the project lifecycle
  • Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency, and quality
  • Manage CRA resourcing, site assignments, visit schedules and serve as the initial point of contact for clinical operations and monitoring issues
  • Review and approve site monitoring visit reports; monitor and track related metrics for compliance with Clinical Monitoring Plan and SOPs
  • Conduct monitoring visits, co-monitoring visits, assessment visits, and/or team training as necessary

51-200 employees

Clinical trial infrastructure company