Senior Clinical Trial Manager

We're looking for a Senior Clinical Trials Manager who will own the end-to-end execution of our clinical studies, including regulatory trials. This is a hands-on, operationally intense position for someone who knows how to stand up a study from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, and drive studies to completion on time and on budget. You'll be the connective tissue between our internal teams and the external clinical sites, investigators, IRBs, CROs, and, when necessary, study subjects directly. You'll bring deep fluency in regulatory requirements for medical devices, and you'll have a track record of delivering clinical studies that have supported regulatory submissions.

Responsibilities

Own clinical study execution from protocol development through final study report; Write and manage IRB/Ethics submissions, informed consent forms, and essential documents; Select, qualify, and oversee third-party clinical sites and investigators; Manage clinical data operations, including CRF/eCRF design, data review, query resolution, and coordination with vendors; Communicate directly with study sites and subjects as needed; Develop and maintain study timelines, budgets, and risk mitigation plans; Ensure compliance with FDA regulations, ICH-GCP, ISO 14155, and applicable SaMD guidance; Manage relationships with CROs and clinical vendors; Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams; Build and scale the clinical operations function

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, including site selection, activation, monitoring, and close-out; 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 - 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; Experience with clinical study budgeting, vendor management, and CRO oversight; Excellent written and verbal communication; Bachelor's degree required

Nice to have

Advanced degree (MS, MPH, PhD, or clinical doctorate) preferred; ACRP or SOCRA certification; 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

Benefits

Equity participation; Performance-based incentives; Your own Pod; Full access to health, vision, and dental insurance for you and your dependents; Other perks