Senior Clinical Trial Manager

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We're here to build fast, push limits, and deliver without compromise. If you thrive under pressure and want to do the most meaningful work of your career, you'll feel right  you're looking for something easier - this isn't it.

The Role

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.

What You'll Do

* 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.

* Select, qualify, and oversee third-party clinical sites and investigators. Serve as the primary point of contact for site teams, ensuring protocol compliance, enrollment targets, and data quality.

* Manage clinical data operations, including CRF/eCRF design, data review, query resolution, and coordination with data management vendors or internal teams.

* Communicate directly with study sites and subjects as needed - you're comfortable picking up the phone and solving problems in real time.

* 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.

What You Bring

* 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.

* 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 (e.g., FDA Digital Health frameworks).

* Experience with clinical study budgeting, vendor management, and CRO oversight.

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