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2 дня назад

Clinical Trial Manager (Medical Device Clinical Research)

95 000 - 130 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Clinical Trial Manager (Medical Device Clinical Research): Managing clinical study sites, documentation, vendors, and operational activities for AI-driven cardiovascular medical device trials with an accent on trial execution, regulatory compliance, and cross-functional coordination. Focus on developing study timelines and protocols, reviewing IRB and informed consent documentation, and maintaining quality under shifting priorities.

Location: Remote within the Central Midwest region, with targeted locations including Chicago, Minneapolis, Dallas, Houston, Austin, and Atlanta; travel required up to 25%.

Base salary: $95,000–$130,000 annually, plus cash bonus.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive solutions for diagnosing and managing coronary artery disease.

What you will do

  • Oversee clinical operational activities at the trial and site level.
  • Manage clinical study sites, study documentation, vendors, and project management activities.
  • Develop trial timelines, enrollment projections, communication plans, monitoring plans, recruitment plans, and risk mitigation strategies.
  • Lead study start-up activities, including protocols, informed consent forms, source document worksheets, and training materials.
  • Review regulatory documents, including informed consents, IRB approvals, and research agreements.
  • Collaborate with clinical research staff, investigators, site coordinators, vendors, data management teams, and core laboratories.

Requirements

  • Bachelor’s degree in science or a health-related field.
  • At least 5 years of relevant clinical research experience.
  • Knowledge of ICH Guidelines, US FDA requirements, European clinical trial regulations, and GCPs.
  • Excellent written and oral English communication skills required.
  • Strong organizational skills, attention to detail, accuracy, prioritization, and ability to manage multiple projects.
  • Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.

Nice to have

  • Experience in cardiovascular medical device clinical research.
  • Experience working in a fast-paced startup environment or smaller team.

Culture & Benefits

  • Remote position with regional focus and up to 25% travel.
  • Collaborative work with clinical research, field, site, investigator, and vendor stakeholders.
  • Opportunities to participate in process improvement and SOP development.
  • Work environment centered on inclusion, respect, and equal opportunity.

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