Eight Sleep

Senior Clinical Trial Manager

Boston Area · Senior · Full-time

Sponsorship not specified$140k-$175kDetected 110 days ago

GCPData ScienceNegotiationBudgetingVendor ManagementClinical TrialsFDA RegulatoryMedical DevicesLeadershipCommunicationRegulatory Affairs

About the role

You'll be the connective tissue between our internal teams and the external clinical sites, investigators, IRBs, CROs, and, when necessary, study subjects directly.

Own clinical study execution from protocol development through final study report - including feasibility, site selection, activation, enrollment management, monitoring, and close-out.
Write and manage IRB/Ethics submissions, informed consent forms (ICFs), and all study-related essential documents.
Manage clinical data operations, including CRF/eCRF design, data review, query resolution, and coordination with data management vendors or internal teams.
Develop and maintain study timelines, budgets, and risk mitigation plans. Flag issues early, propose solutions, and keep leadership informed with clear, concise reporting.
Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and applicable SaMD guidance documents.
Manage relationships with CROs and other clinical vendors, including contract negotiation, performance oversight, and issue resolution.
Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.
Build and scale the clinical operations function - develop SOPs, templates, tracking systems, and processes that can grow with the company.

Proven ability to author IRB/Ethics submissions, informed consent forms, and clinical protocols.
3+ years experience of cross-functional program management, involving clinical, engineering, and regulatory teams.
Experience with clinical study budgeting, vendor management, and CRO oversight.
Excellent written and verbal communication - you can draft a protocol, run a site initiation visit, and present enrollment updates to executives with equal confidence.
Experience supporting FDA breakthrough device designations or pre-submission meetings.
5+ years of hands-on clinical operations experience executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products. We want someone who has run trials - not just reviewed them from the regulatory side.
Demonstrated experience managing third-party clinical sites, including site selection, activation, monitoring, and close-out.
Strong working knowledge of clinical data management - eCRF design, data cleaning, query management, and database lock processes.
Fluency in FDA device regulations (IDE, De Novo, 510(k) clinical requirements), ICH-GCP, ISO 14155, and familiarity with SaMD-specific guidance (e.g., FDA Digital Health frameworks).
Experience with biosensing devices, consumer health technology, or wellness platforms pursuing clinical validation.
Familiarity with real-world evidence (RWE) study designs and decentralized / hybrid clinical trial models.

Target Base Salary: $140,000 - $175,000
Compensation is based on experience, qualifications, and market benchmarks for the Boston metro area. Equity and performance-based incentives are a significant component of total compensation at Eight Sleep.

As the world's first sleep fitness company, we're redefining what it means to be well-rested and building the most advanced hardware, software, and AI technology to make it possible.
We are trusted by high performers, professional athletes, and health-conscious consumers in over 30 countries worldwide.
5+ years of hands-on clinical operations experience executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.

At Eight Sleep, we're on a mission to fuel human potential through optimal sleep.

As an equal opportunity employer, we stay true to our values by ensuring everyone feels they can flourish and grow.

al employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status

This listing is sourced directly from Eight Sleep's careers page and normalized into a canonical job model.