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3 часа назад

Senior Manager, Clinical Operations (Medical Devices)

150 000 - 175 000$
Формат работы
hybrid
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
Senior Manager, Clinical Operations (Medical Devices): Leading clinical trial design, development, and execution for medical-device therapies with an accent on clinical operations, regulatory compliance, and cross-functional leadership. Focus on managing sites, CROs, budgets, risk-based monitoring, audit readiness, and developing high-performing clinical teams.

Location: Hybrid in Minnetonka, Minnesota, United States; expected to work 3–4 days per week in the office

Annual base salary: $150,000–$175,000, plus bonus eligibility.

Company

hirify.global develops medical devices, software, and related services for serious cardiopulmonary and respiratory conditions. The Respicardia division develops therapies for central sleep apnea.

What you will do

  • Lead clinical trial operational execution, including site and investigator selection, recruitment, monitoring, investigator meetings, trial master files, and site performance issue resolution.
  • Develop clinical study protocols, procedures, and supporting documentation across all phases of development.
  • Manage internal teams, CROs, vendors, and consultants supporting clinical programs.
  • Own resource allocation, study budgets, timelines, and remote and risk-based monitoring strategies.
  • Coordinate site initiation, recruitment, preparation, IRB approval, enrollment readiness, and education for site and field personnel.
  • Provide leadership updates, support audit readiness, maintain compliance, and oversee team workload, performance, hiring, and development.

Requirements

  • Bachelor’s degree in a scientific field and demonstrated clinical research experience; an advanced degree is preferred.
  • 5+ years of leadership experience in clinical or scientific research within the medical-device industry, including 3–4+ years of direct people management.
  • Experience with clinical research centers across site activation, enrollment, and closeout phases.
  • Proficiency with CTMS, EDC, and eTMF systems, as well as risk-based quality management and monitoring.
  • Knowledge of GCP, ISO, CFR, European MDR, and applicable global regulatory standards.
  • Strong communication, project management, analytical, problem-solving, stakeholder management, and clinical data presentation skills; ability to travel, including overnight stays, 25%.

Nice to have

  • Experience in cardiology or sleep medicine.
  • Experience with Premarket Approval medical devices.
  • Advanced scientific degree.

Culture & Benefits

  • Hybrid flexibility with regular in-office collaboration.
  • Work focused on improving outcomes for underserved patients with critical cardiopulmonary conditions.
  • Innovation, self-motivation, and an entrepreneurial spirit are valued.
  • Comprehensive benefits and annual bonus plan.
  • Company operations span more than 140 countries.

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