Manager of Clinical Research, AQMed

SandboxAQ

7d • $131,200 - $246,000

About The Position

AQMed is developing a next-generation, non-invasive cardiac diagnostic platform designed to revolutionize how heart health is assessed. The team operates at the intersection of regulated medical device development and fast-paced startup innovation, with a strong emphasis on quality, scientific rigor, and patient safety. We are seeking a Manager of Clinical Research who will own and accelerate AQMed's clinical program. You will inherit a meaningful foundation — established processes and early clinical work already underway — and take it to the next level. You will drive execution of a multi-geography clinical program from feasibility to pivotal studies, working alongside external support (e.g. consultants, CRO) while serving as the internal authority and integrating point for all things clinical. We are looking for a resourceful, deeply experienced clinical operator who thrives in ambiguity and moves with urgency. You bring proven multi-center trial leadership, global site management experience, and the judgment to make smart and data-driven decisions. You are equally comfortable in a site coordinator meeting, an FDA pre-submission discussion, or a cross-functional planning sprint — and you do whatever it takes to keep the program moving. Notably, you are AI-forward: curious about how AI tools can accelerate clinical research workflows, and eager to apply them to improve speed, quality, and efficiency across the program.

Requirements

• 10+ years of clinical research experience in medical devices or diagnostics, with hands-on execution responsibility across the full study lifecycle.
• Demonstrated success leading multi-center clinical trials across multiple geographies, including site management, IRB/EC submissions, and regulatory coordination. Proven track record across multiple study types: feasibility studies, pivotal studies both US & OUS.
• Strong working knowledge of 21 CFR Parts 812/820, ISO 14155, EU MDR.
• Exceptional organizational and program management skills — you can hold 10 moving pieces without dropping any.
• Excellent communicator: equally effective in a site initiation visit, a cross-functional standup, and an executive briefing.
• Experience as the primary clinical lead on studies that directly supported a regulatory submission (510(k), De Novo, or CE Mark).
• Demonstrated ability to manage CROs and/or external clinical consultants with accountability and precision.

Nice To Haves

• Experience in cardiology, electrophysiology, or cardiovascular diagnostics — ideally with capital equipment or software-enabled diagnostic devices.
• Familiarity with FDA De Novo, SaMD regulatory pathways, and AI/ML-based medical device submissions.
• Prior experience as the founding or first clinical hire at a startup or early-stage medtech company — you know what it means to lead clinical on a lean & fast-moving team.
• Comfort working in a fast-moving, resource-constrained environment where creativity and ownership matter more than process for its own sake.
• AI-forward mindset: demonstrated curiosity and hands-on use of AI tools to accelerate clinical research workflows. Examples may include protocol development, site communication, data review or timeline management, with an eagerness to apply this AI-forward mindset into daily practice.
• Active network of clinical investigators and site coordinators in cardiology or emergency medicine across the US and internationally.
• Bachelor's or advanced degree in life sciences, clinical research, nursing, or a related field; CRA, CCRA, or CCRP certification a plus.

Responsibilities

• Own end-to-end execution of AQMed's clinical study portfolio, from feasibility through pivotal and across the US, Europe, and Asia.
• Develop and maintain clinical study plans, protocols, budgets, agreements, timelines; proactively identify and resolve threats to enrollment, data quality, and regulatory timelines.
• Lead site identification, qualification, initiation, monitoring, and close-out across multi-center, multi-geography studies.
• Serve as the primary operational owner of all IRB/ Ethics Committee submissions, amendments, and ongoing reporting requirements.
• Select, onboard, and manage external clinical consultants and/or CRO partners; hold them to high standards of quality, speed, and accountability.
• Define clear scopes of work, success metrics, and escalation paths for all external clinical resources.
• Build and sustain trusted relationships with clinical investigators, coordinators, and hospital administration at each study site.
• Drive enrollment with creativity and urgency; designing site-specific strategies, troubleshooting bottlenecks, and escalating risks early.
• Conduct or coordinate site visits (in-person and remote) and ensure protocol adherence, data integrity, and GCP compliance at all sites.
• Collaborate with Product, Data Science, and Engineering to ensure study designs generate data that is both clinically meaningful, actionable and useful.
• Partner with regulatory & quality on clinical inputs for 510(k)/ De Novo submissions, FDA interactions, and QMS compliance (21 CFR Parts 812/820, ISO 14155, EU MDR guidelines).
• Partner with the GM and VP of Commercial Strategy on evidence strategy — which studies to run, which endpoints matter, and how clinical data supports the indication roadmap and reimbursement narrative.
• Represent AQMed's clinical program credibly with investigators, hospital partners, SAB members.

Benefits

• Comprehensive medical, dental, and vision coverage for employees and dependents with generous employer premium contributions
• Retirement savings with company matching
• Paid parental leave
• Inclusive family-building benefits
• Flexible paid time off
• Company-wide seasonal breaks
• Support for flexible work arrangements that enable sustainable performance
• Opportunities for continuous learning and growth through on-the-job development, cross-functional collaboration, and access to internal learning and development programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager