Clinical Trial Manager

HeartFlow Logo

HeartFlow

πŸ’΅ $85k-$140k
πŸ“Remote - United States

Summary

Join HeartFlow, a medical technology company revolutionizing precision heart care, as a Clinical Trial Manager (CTM). The CTM will oversee and manage all clinical operational activities at the trial and site level, ensuring clinical studies meet or exceed timelines and maintain high quality standards. This role requires collaboration with various stakeholders, including HeartFlow staff, clinical research coordinators, principal investigators, and vendors. The ideal candidate will possess strong organizational skills, attention to detail, and experience in clinical research study execution. HeartFlow offers a competitive salary, bonus, and stock options, along with a fast-paced, startup environment. The position is open to remote work.

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

Responsibilities

  • Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
  • Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
  • Participates in and leads process improvement activities within the department and cross functionally, including SOP development
  • Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc
  • Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
  • Maintains 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

Preferred Qualifications

Experience in cardiovascular medical device clinical research a plus

Benefits

  • A reasonable estimate of the base salary compensation range is $95,000 to $140,000 (for San Francisco Bay Area) and $85,000 to $115,500 (for all areas outside of San Francisco Bay Area), cash bonus, and stock options
  • #LI-Remote

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