Senior Clinical Trial Manager
Eight Sleep
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $140,000 - $175,000 per year
Job Level
About the role
- Own clinical study execution from protocol development through final study report
- Write and manage IRB/Ethics submissions and essential documents
- Select, qualify, and oversee third-party clinical sites and investigators
- Manage clinical data operations and ensure compliance with FDA regulations
- Communicate directly with study sites and subjects as needed
- Develop and maintain study timelines, budgets, and risk mitigation plans
- Manage relationships with CROs and other clinical vendors
- Collaborate cross-functionally with various teams to ensure clinical strategies align with product development
Requirements
- 5+ years of hands-on clinical operations experience executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products
- Demonstrated experience managing third-party clinical sites
- Proven ability to author IRB/Ethics submissions, informed consent forms, and clinical protocols
- 3+ years experience of cross-functional program management
- Strong working knowledge of clinical data management
- Fluency in FDA device regulations (IDE, De Novo, 510(k) clinical requirements)
- Experience with clinical study budgeting, vendor management, and CRO oversight
- Excellent written and verbal communication
- Bachelor's degree required; advanced degree preferred
- ACRP or SOCRA certification is a plus
Benefits
- Health, vision, and dental insurance for you and your dependents
- Equity participation available
- Opportunity for immediate responsibility and accelerated career growth
- Employee access to the company's product (Pod)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study executionprotocol developmentIRB submissionsclinical data managementclinical study budgetingvendor managementCRO oversightrisk mitigation planninginformed consent formsclinical protocols
Soft Skills
communicationcross-functional collaborationrelationship managementprogram management
Certifications
ACRP certificationSOCRA certification