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Clinical Trial Lead
Confirmed live in the last 24 hours
San Francisco, CA, USA • Remote
Experience Level
  • Minimum of five (5) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
  • Minimum of one (1) 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
  • Or equivalent demonstrated skill set
  • Plus: In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the critical elements of success
  • Manage clinical operations deliverables including timeline, quality, scope, and financials
  • Works 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
  • Anticipate client needs and proactively resolve issues as necessary
  • 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 Highline SOPs
  • Conduct monitoring visits, co-monitoring visits, assessment visits and/or team training as necessary
Desired Qualifications
  • Prior experience in a Clinical Research Associate related role at a CRO, biotech or pharma company
  • Early phase clinical trial experience

1,001-5,000 employees

Data-driven precision medicine
Company Overview
Tempus is on a mission to provide the necessary tools to usher in an era of precision medicine. The company has built the world's largest library of clinical and molecular data and an operating system to make that information accessible and useful for patients, physicians, and researchers.