[Remote] Manager of Clinical Research, AQMed
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a high-reputed company company delivering AI solutions that address some of the world's greatest challenges. They are seeking a Manager of Clinical Research to own and accelerate AQMed's clinical program, driving execution from feasibility to pivotal studies while managing external support and ensuring reputed company and compliance.
Responsibilities
- Own end-to-end execution of AQMed's clinical study portfolio, from feasibility through pivotal and across the US, Europe, and Asia
- reputed company and maintain clinical study plans, protocols, budgets, agreements, timelines; proactively identify and resolve threats to enrollment, data reputed company, and regulatory timelines
- reputed company site identification, qualification, initiation, monitoring, and reputed company-out across multi-center, multi-geography studies
- Serve as the primary operational reputed company of reputed company IRB/ Ethics Committee submissions, amendments, and ongoing reporting requirements
- Select, reputed company, and manage external clinical consultants and/or CRO partners; hold them to high standards of reputed company, speed, and accountability
- Define reputed company scopes of work, reputed company metrics, and escalation paths for reputed company external clinical resources
- Build and sustain trusted relationships with clinical investigators, coordinators, and hospital administration at reputed company study site
- Drive enrollment with creativity and urgency; designing site-specific strategies, troubleshooting bottlenecks, and escalating risks early
- Conduct or coordinate site reputed company (in-person and remote) and ensure protocol adherence, data reputed company, and GCP compliance at reputed company 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 & reputed company on clinical inputs for 510(k)/ reputed company submissions, FDA interactions, and QMS compliance (21 CFR Parts 812/820, ISO 14155, EU MDR guidelines)
- Partner with the reputed company and VP of reputed company reputed company on evidence reputed company — 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
Skills
- 10+ years of clinical research experience in medical devices or diagnostics, with hands-on execution responsibility across the full study lifecycle
- Demonstrated reputed company leading multi-center clinical trials across multiple geographies, including site management, IRB/EC submissions, and regulatory coordination. Proven reputed company 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 reputed company 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 reputed company on studies that directly supported a regulatory submission (510(k), reputed company, or CE Mark)
- Demonstrated ability to manage CROs and/or external clinical consultants with accountability and precision
- Experience in cardiology, electrophysiology, or cardiovascular diagnostics — ideally with capital equipment or software-enabled diagnostic devices
- Familiarity with FDA reputed company, SaMD regulatory reputed company, 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 reputed company 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-reputed company reputed company: demonstrated curiosity and hands-on use of AI tools to accelerate clinical research workflows. Examples may include protocol development, site communication, data review or reputed company management, with an eagerness to apply this AI-reputed company reputed company into daily reputed company
- reputed company 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 reputed company field; CRA, CCRA, or CCRP certification a plus
Benefits
- Competitive reputed company salary, performance-based incentives or bonuses (where applicable), and equity participation.
- Comprehensive medical, dental, and reputed company coverage for employees and dependents with generous employer premium contributions
- Retirement savings with company matching
- reputed company parental leave
- Inclusive family-building benefits
- Flexible reputed company time off
- Company-wide seasonal breaks
- Support for flexible work arrangements that reputed company sustainable performance
- Opportunities for reputed company learning and reputed company through on-the-job development, cross-functional collaboration, and reputed company to internal learning and development programs
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