2 часа назад
Sr. Clinical Research Project Manager (Medtech)
115 000 - 149 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr. Clinical Research Project Manager (Medtech): Leading complex domestic and international clinical research projects with an accent on cross-functional coordination, regulatory compliance, study budgets, and timelines. Focus on managing clinical trial vendors and monitors, developing risk mitigation and quality control plans, and ensuring accurate study data under Good Clinical Practice guidelines.
Location: Remote - US; occasional travel of up to 10%, including possible international travel, may be required.
Salary: $115,000–$149,000 per year
Company
is a digital healthcare company creating wearable biosensors, cloud-based data analytics, and proprietary algorithms for cardiac health.
What you will do
- Lead the planning, execution, and completion of complex sponsor-initiated, RaaS, and investigator-initiated clinical research studies.
- Coordinate cross-functional teams and monitor progress against study protocols, timelines, budgets, and standard operating procedures.
- Develop and review protocols, informed consent forms, case report forms, study manuals, reports, presentations, and publications.
- Lead study start-up activities, including site identification, feasibility assessments, and study initiation visits.
- Manage CROs, external service providers, study monitors, contracts, budgets, forecasting, and expense tracking.
- Develop risk management and quality control plans, maintain stakeholder relationships, and mentor junior staff.
Requirements
- Bachelor’s degree in a health-related field or relevant clinical research experience.
- 8+ years of experience in clinical research project management or a related field, with a record of managing complex studies.
- In-depth knowledge of regulatory requirements and Good Clinical Practice guidelines.
- Experience with clinical trial budgets and financial management, electronic data capture systems, and clinical trial management systems.
- Strong organizational, communication, problem-solving, leadership, and prioritization skills.
- Ability to lead cross-functional teams in a fast-paced, deadline-driven environment and willingness to work occasional evenings or weekends.
Nice to have
- Experience with ISO 14155 and other international clinical research guidelines.
Culture & Benefits
- Fully remote full-time work with a collaborative and supportive clinical research environment.
- Occasional travel to team offsites, conferences, and role-related activities.
- Inclusive workplace welcoming diverse backgrounds, experiences, skills, and perspectives.
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