3 часа назад
Senior Manager, Clinical Operations (Medical Devices)
150 000 - 175 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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