2 дня назад
Clinical Trial Manager (Medical Device Clinical Research)
95 000 - 130 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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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