Senior Clinical Research Scientist

Employment Type: Full-time Location Type: Fully Remote (United States)

Position Overview

iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. We are seeking an experienced and motivated Senior Clinical Research Scientist to provide leadership in clinical study design, analysis, and medical/scientific writing as part of its PRISM organization (Product Management, Research, Innovation, Scientific Affairs, Medical Affairs). This is a unique opportunity to work as part of a highly collaborative team tasked with driving iRhythm’s product innovation, developing clinical strategies, and disseminating evidence.

The Senior Clinical Research Scientist is responsible for the leading scientific aspects of clinical research for assigned project(s) and will work closely with Clinical Research Operations, Biostatistics and Data Management, other iRhythm functions, and external partners to deliver impactful clinical evidence. In concert with the clinical director, this role is accountable for achieving the successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope, and budget constraints.

This is a fully remote position, allowing you to work from anywhere within the United States. Candidates must have a reliable internet connection and a dedicated workspace to ensure productivity.

Responsibilities

• Proactively manage project-level scientific aspects of clinical research projects, including study design, analysis, and evidence dissemination.
• Support the Clinical Science function in the development of clinical evidence strategies.
• Work closely with internal stakeholders (product management, regulatory, R&D, data management, and biostatistics) and external stakeholders (clinical thought leaders and other subject matter experts) to ensure the robustness of clinical findings and alignment of evidence to iRhythm's strategic goals.
• Lead the development of clinical study design and study protocols for prospective trials in support of market clearance and post-market clinical evidence.
• Develop analysis plans and study protocols for targeted analysis of existing datasets, including prior device registrations and other real-world evidence.
• Drive analysis and interpretation of prospective clinical data and real-world evidence with data management and biostatistics.
• Lead evidence dissemination for clinical applications and product programs through:
  • Scientific writing, including drafting and submission of conference abstracts and peer-reviewed journal articles.
  • Development of posters and slides for scientific meetings.
  • Collaboration with internal and external co-authors through steering committees, investigator meetings, and one-on-one communication.
• Provide cross-functional support to health economics and outcomes research (HEOR) and regulatory teams, including the development of US and Global regulatory-clinical documentation (e.g., CSRs, CERs).
• Participate in the review of external investigator-initiated research proposals for scientific merit and alignment with iRhythm objectives.
• Periodically provide updates on study progress with respect to the project plan.
• Partner with Clinical Research Operations to ensure the timeliness of clinical study execution, mitigation of project risks, and adherence to quality standards, standard operating procedures (SOPs), and regulatory requirements.

Company Information

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. We are shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you – curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career.