Senior Clinical Research Scientist
New
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
- Data AnalysisGCP
Requirements
- Advanced degree in Biomedical Science or Health-related field (MD or PhD preferred).
- 10+ years of clinical science or clinical development experience in medical device, academic, or commercial research organizations.
- Knowledge of clinical research operations, specifically GCP and ISO 14155.
- Experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, or related cardiovascular fields.
- Expertise in observational study design and clinical trial design.
- Working knowledge of diagnostic testing metrics (Sensitivity, Specificity, PPV, NPV).
- Understanding of FDA and EU medical device and SaMD regulations.
- Knowledge of intermediate biostatistics and causal inference.
- Strong scientific writing skills for study reports, abstracts, and manuscripts.
- Experience with US and EU clinical-regulatory documentation (e.g., 510(k), IDE, PMA, CER).
- Proficiency in program management and project oversight.
- Fluent in English with effective presentation skills.
- Ability and willingness to travel domestically and internationally up to 30%.
Responsibilities
- Manage project-level scientific aspects of clinical research, including study design, analysis, and evidence dissemination.
- Support the development of clinical evidence strategies within the Clinical Science function.
- Collaborate with internal teams (R&D, regulatory, biostatistics) and external thought leaders to ensure robust clinical findings.
- Lead the development of clinical study designs and protocols for prospective trials and targeted analysis of existing datasets.
- Drive the analysis and interpretation of clinical data in partnership with biostatistics and data management teams.
- Lead evidence dissemination through scientific writing, including conference abstracts, peer-reviewed articles, and scientific presentations.
- Provide cross-functional support for HEOR and regulatory teams, including drafting CSRs, CERs, and regulatory documentation.
- Participate in the review of investigator-initiated research proposals.
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