Clinical Trial Manager

Clinical ResearchClinical ResearchFull TimeRemoteTeam 201-500Since 2010H1B No SponsorCompany SiteLinkedIn

Location

Illinois + 2 moreAll locations: Illinois, Minnesota, Texas

Posted

170 days ago

Salary

$95K - $125K / year

Bachelor Degree5 yrs expEnglish

Job Description

• Oversight and management of all clinical operational activities at the trial and site level • Interact with Heartflow Clinical Research staff and collaborate with onsite and field staff, clinical research coordinators, principal investigators, and vendors • Develop clinical trial timelines, enrollment projections, instructional materials, and project, communication, monitoring, recruitment, risk mitigation, and contingency plans • Participate in and lead process improvement activities, including SOP development • Conduct study start-up activities including development of protocols, informed consent forms, source document worksheets, and training presentations • Review site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs • Maintain effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management • Perform other duties as required for successfully completing studies, as necessary

Job Requirements

  • Ability to work in a smaller team environment with a willing, all hands on deck attitude
  • Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
  • High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
  • Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
  • Excellent written and oral English communication skills required
  • Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint
  • Bachelor’s degree in science or health related field
  • Demonstrated 5 years minimum relevant experience required
  • Experience in cardiovascular medical device clinical research a plus
  • Travel required: up to 25%

Benefits

  • cash bonus

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