Senior Manager, Clinical Research

Senior Manager, Clinical Research

Butterfly Network, Inc. (NYSE: BFLY) is driving a digital revolution in ultrasound imaging and sensing with its proprietary Ultrasound-on-Chip™ semiconductor technology and software solutions. Butterfly first proved its technology in the point-of-care ultrasound market – commercializing the world's first single-probe, whole-body portable ultrasound device, which is now on its best-selling, third-generation:
Butterfly iQ3™. The Company combines its advanced hardware with cloud software and AI, an enterprise workflow solution (Compass AI™) and other offerings to drive adoption of affordable, accessible ultrasound. Butterfly also enables third-party development of imaging AI apps through Butterfly Garden™, its software development kit and AI partnership initiative.

In addition to its medical imaging products, Butterfly Embedded™ is the Company's Ultrasound-on-Chip™ licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Butterfly's innovations have been recognized by Prix Galien USA, Fierce 50, TIME's Best Inventions and Fast Company's World Changing Ideas, among other achievements.

We're a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let's build something extraordinary together!

We are seeking an organized, detail-oriented Clinical Operations Manager to oversee the execution, compliance, and documentation of our clinical portfolios. In this role, you will not lead primary protocol design. Instead, you will act as the operational backbone of our clinical efforts. You will keep track of Investigator-Initiated Trials (IITs), manage rigorous verification and validation (V&V) paperwork, and draft Institutional Review Board (IRB) submissions.

You will also manage one direct report (Clinical Coordinator) to ensure clinical projects hit timelines and meet regulatory standards.

Your core responsibilities will be:

• Trial Tracking & Investigator Support
• Serve as the primary operational point of contact for external clinicians managing Investigator-Initiated Trials (IITs).
• Maintain rigorous tracking systems for milestones, data collection timelines, and budget disbursements for all ongoing IITs.
• Ensure external investigators comply with study agreements, safety reporting, and data publication timelines.
• Regulatory, IRB & Compliance Documentation
• Lead the drafting, formatting, and submission of Institutional Review Board (IRB) applications, amendments, and annual renewals.
• Cross-functionally collaborate with Engineering and Quality Assurance (QA) teams to organize, maintain, and audit internal Verification and Validation (V&V) documentation.
• Ensure all trial master files (TMF) and study documentation are audit-ready and compliant with FDA, ISO 14155, and Good Clinical Practice (GCP) guidelines.
• Leadership & Operations
• Manage, mentor, and delegate tasks to a Clinical Coordinator, ensuring efficient daily operational workflows.
• Keep internal stakeholders (R&D, Regulatory, and Executive teams) updated on trial metrics, data collection bottlenecks, and compliance health.

• Experience:
  
  4–6+ years of clinical research experience within the medical device, medtech, or digital health space.
• Management:
  Prior experience managing or mentoring junior clinical staff (e.g., Clinical Coordinators or Assistants).
• Skills:
  
  Demonstrated success handling IRB submissions, maintaining TMFs, and tracking multisite trials or IITs.
• Knowledge:
  Deep familiarity with medical device documentation, internal V&V processes, GCP, and FDA regulations.
• Education:
  
  Bachelor's degree in a scientific, nursing, or healthcare-related field (CCRP or CCRA certification is a strong plus).

Innovation is what we do. Our values are how we make it happen. Butterflies are and believe in…

• Patient-Centric Innovators:
  Our mission is THE mission.
• Empowered to Impact:
  Every voice matters.
• One Team, One Goal:
  Unity fuels progress.
• Growth Champions:
  We embrace challenges.
• Action-Oriented Achievers:
  We follow through, every time.

Butterfly offers a hybrid work…