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iRhythm Technologies, Inc.

Sr Clinical Scientist

RemoteUnited States only
Published
Role
Research
Experience
Senior
Employment
Full-time
Company size
Enterprise
$150k–$180k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior clinical research scientist with 10+ years in medical device/clinical development or academic/ARO/CRO settings. Must have cardiovascular/heart rhythm clinical research experience and strong skills in study design, GCP/medical device regulations, and scientific writing. Remote within the United States only; willingness to travel (<30%).

Core skills

clinical study designscientific writing

Required skills

GCPISO 14155clinical trialsobservational study designbiostatisticscausal inferencesensitivityspecificityPPVNPVclinical study reportsconference abstractsmanuscriptsmedical device regulatory documentationSaMD

Optional skills

510(k)IDEPMACERHEORreal-world evidence

Required languages

English Fluent

What you'll do

  • Proactively manage project-level scientific aspects of clinical research projects, including study design, analysis, and evidence dissemination
  • Support the Clinical Science function in development of clinical evidence strategies
  • Work closely with internal and external stakeholders to ensure robustness of clinical findings and alignment of evidence to iRhythm strategic goals
  • Lead 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
  • With data management and biostatistics, drive analysis and interpretation of prospective clinical data and real-world evidence
  • Lead evidence dissemination through scientific writing, conference abstracts, peer-reviewed journal articles, and development of posters/slides
  • Collaborate with internal and external co-authors through steering committees, investigator meetings and 1-on-1 communication
  • Cross-functional support of HEOR and regulatory teams, including development of US and Global regulatory-clinical documentation (e.g., CSRs, CERs)
  • Participate in review of external investigator-initiated research proposals for scientific merit and alignment with iRhythm objectives
  • Provide periodic updates on study progress and partner with clinical research operations to ensure timeliness, risk mitigation, SOP adherence, and regulatory compliance

What they require

  • Advanced Degree in Biomedical Science or Health-related field required (MD, PhD preferred)
  • Ten or more years of clinical science or clinical development experience in medical device or related industries or in high-performing academic medical centers/universities, or academic or commercial research organizations (AROs/CROs)
  • Knowledge of clinical research operations including GCP and ISO 14155
  • Clinical research experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, cardiology or a related field (Cardiovascular experience strongly preferred)
  • Experience in observational study design and execution (health services and outcomes research) as well as clinical trial design
  • Strong understanding of causal inference
  • Working knowledge of metrics associated with diagnostic testing accuracy (Sensitivity, Specificity, PPV, NPV)
  • Demonstrated working knowledge of FDA and EU regulations regarding medical devices and SaMD
  • Substantive experience with study design including clinical trials and observational designs
  • Understanding of basic and intermediate biostatistics
  • Strong writing skills and experience in writing clinical study reports, conference abstracts, and manuscripts for peer-reviewed journals
  • Experience with US and EU clinical-regulatory documentation preferred (e.g., 510(k), IDE, PMA, and CER)
  • Demonstrated ability to collaborate effectively with cross-functional teams
  • Experience in program management and project oversight
  • Read, write and speak fluent English; ability to present information to a variety of audiences
  • Willingness and ability to travel domestically and internationally (anticipated <30% of work time)

Benefits

  • Medical, dental, and vision insurances starting on first day
  • Health savings account employer contributions (when enrolled in high deductible medical plan)
  • Cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts)
  • Travel reimbursement for medical care
  • Noncontributory basic life insurance & short/long term disability
  • Emotional health support for you and your loved ones
  • Legal / financial / identity theft/ pet and child referral assistance
  • Paid parental leave
  • Paid holidays
  • Travel assistance for personal trips
  • Paid time off (PTO)
  • 401(k) with company match
  • Employee Stock Purchase Plan
  • Pet insurance discount
  • LinkedIn Learning classes

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information.

HealthcareEnterprise
$150k–$180k/yr