5 дней назад
Clinical Trial Manager (Class III Medical Devices)
117 000 - 156 750$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (Class III Medical Devices) (Medical Devices): Managing the execution and coordination of clinical trials for Class III implantable devices with an accent on study operations, vendor oversight, site management, and regulatory compliance. Focus on tracking timelines and data quality, identifying operational risks, coordinating CROs and study sites, and supporting safety reporting and protocol amendments.
Location: Remote, USA
Base salary: $117,000–$156,750 per year
Company
is a mid-sized biotechnology company developing life-changing medicines and supporting clinical research for products that improve patient care.
What you will do
- Manage the day-to-day execution and coordination of clinical trials for Class III implantable medical devices.
- Track study activities, timelines, deliverables, operational metrics, action items, and issue logs.
- Coordinate with study sites, CROs, external vendors, and cross-functional partners to maintain protocol compliance, quality, and study continuity.
- Monitor trial progress, identify operational risks affecting timelines or data quality, and support issue resolution.
- Support vendor oversight, site management, trial documentation, regulatory submissions, protocol amendments, and safety reporting workflows.
- Collaborate with Safety, Regulatory, Quality, and Data Management teams.
Requirements
- Bachelor’s degree required; advanced degree preferred.
- At least 5 years of experience in clinical research or clinical operations.
- Experience supporting clinical trials for Class III implantable medical devices.
- Strong organizational and communication skills, with the ability to manage competing priorities and tight timelines.
- Knowledge of regulatory and quality standards, vendor oversight, site management, regulatory submissions, protocol amendments, and safety reporting workflows.
- Must be based in the USA for this remote role.
Culture & Benefits
- Full-time employment with medical, dental, vision, and life insurance.
- Short- and long-term disability insurance, paid vacation, sick time, holidays, and parental leave.
- 401(k) program with company matching contributions and an employee stock purchase plan.
- Short-term and long-term incentives, including cash bonuses and equity opportunities.
- Fitness and wellness programs, tuition reimbursement of up to $10,000 per year, and Employee Resource Group participation.
- Inclusive environment focused on collaboration, learning, growth, and belonging.
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