Senior Clinical Research Scientist
I
iRhythmDigital Healthcare
This is a fully remote position, allowing you to work from anywhere within the United States.Full-TimeSenior
Salary150,000 - 180,000 USD per year
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Job Details
- Languages
- English
- Experience
- Ten or more years of clinical science or clinical development experience
- Required Skills
- GCP
Requirements
- Advanced degree in Biomedical Science or Health-related field (MD, PhD preferred).
- 10+ years of clinical science or clinical development experience in medical device or related industries, academic medical centers, or CROs.
- Knowledge of clinical research operations including GCP and ISO 14155.
- Clinical research experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, or cardiology.
- Experience in observational study design and execution as well as clinical trial design.
- Strong understanding of causal inference.
- Working knowledge of diagnostic testing accuracy metrics (Sensitivity, Specificity, PPV, NPV).
- Working knowledge of GCP, FDA, and EU regulations regarding medical devices and SaMD.
- Strong writing skills and experience in clinical study reports, conference abstracts, and peer-reviewed manuscripts.
- Ability to collaborate effectively with cross-functional teams.
- Fluent in English.
- Willingness and ability to travel domestically and internationally (up to 30%).
Responsibilities
- 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 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.
- Drive analysis and interpretation of prospective clinical data and real-world evidence.
- Lead evidence dissemination through scientific writing, conference abstracts, peer-reviewed journals, and scientific meeting materials.
- Provide cross-functional support for HEOR and regulatory teams, including development of clinical-regulatory documentation.
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