Senior Clinical Trial Manager (Medtech)

TL;DR

Senior Clinical Trial Manager (Medtech): Owning the end-to-end execution of clinical studies, including regulatory trials, with an accent on standing up studies from scratch, managing third-party clinical sites, and overseeing data management. Focus on driving studies to completion on time and on budget, ensuring compliance with FDA regulations and SaMD guidance.

Location: Hybrid (Boston Area)

Salary: $140,000 – $175,000

Company

hirify.global is a sleep fitness company redefining what it means to be well-rested and building advanced hardware, software, and AI technology.

What you will do

• Own clinical study execution from protocol development through final study report.
• Write and manage IRB/Ethics submissions and informed consent forms.
• Select, qualify, and oversee third-party clinical sites and investigators.
• Manage clinical data operations, including CRF/eCRF design and data review.
• Develop and maintain study timelines, budgets, and risk mitigation plans.
• Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams.

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, involving clinical, engineering, and regulatory teams.
• Strong working knowledge of clinical data management.
• Fluency in FDA device regulations (IDE, De Novo, 510(k) clinical requirements), ICH-GCP, ISO 14155, and familiarity with SaMD-specific guidance.

Nice to have

• 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.
• Prior experience in a high-growth startup or scale-up environment.
• Experience supporting FDA breakthrough device designations or pre-submission meetings.

Culture & Benefits

• Be part of a team that continuously pushes the boundaries of technology in sleep fitness.
• Take on substantial responsibilities that have a direct impact on our core business and product success.
• Work alongside other bright minds.
• Receive equity participation.
• Receive the product that defines our mission.