Manager of Clinical Research

This is a fully remote position, open to applicants in California.

📋 Description

• Take responsibility for the comprehensive execution of AQMed's clinical study portfolio, spanning from feasibility to pivotal stages across the US, Europe, and Asia.

• Create and uphold clinical study plans, protocols, budgets, agreements, and timelines; proactively identify and address challenges related to enrollment, data quality, and regulatory timelines.

• Lead the identification, qualification, initiation, monitoring, and closure of sites for multi-center, multi-geography studies.

• Act as the primary operational owner for all IRB/Ethics Committee submissions, amendments, and ongoing reporting obligations.

• Select, onboard, and oversee external clinical consultants and/or CRO partners; ensure they adhere to high standards of quality, efficiency, and accountability.

• Establish clear scopes of work, success metrics, and escalation protocols for all external clinical resources.

• Cultivate and maintain trusted relationships with clinical investigators, coordinators, and hospital administration at each research site.

• Propel enrollment with innovation and urgency; devise site-specific strategies, resolve bottlenecks, and escalate risks promptly.

• Collaborate with Product, Data Science, and Engineering teams to ensure that study designs yield data that is clinically meaningful, actionable, and beneficial.

⛳️ Requirements

• 10+ years of clinical research experience in medical devices or diagnostics, with direct execution responsibilities throughout the entire study lifecycle.

• Proven success in leading multi-center clinical trials across diverse geographies, including site management, IRB/EC submissions, and regulatory coordination.

• Strong familiarity with 21 CFR Parts 812/820, ISO 14155, and EU MDR standards.

• Outstanding organizational and program management competencies.

• Excellent communicator across various settings.

• Experience as the primary clinical lead on studies that have directly supported a regulatory submission (510(k), De Novo, or CE Mark).

• Proven ability to manage CROs and/or external clinical consultants with accountability and precision.

🏝️ Benefits

• Competitive base salary, along with performance-based incentives or bonuses (where applicable), and equity participation.

• Comprehensive medical, dental, and vision coverage for employees and their dependents, featuring generous employer premium contributions.

• Retirement savings plan with company matching.

• Paid parental leave and inclusive family-building benefits.

• Flexible paid time off, complemented by company-wide seasonal breaks.

• Support for flexible work arrangements that promote sustainable performance.

• Opportunities for continuous learning and growth through on-the-job development, cross-functional collaboration, and access to internal learning and development programs.