Senior Clinical Scientist
New
I
iRhythm TechnologiesMedical devices
Fully remote position, allowing you to work from anywhere within the United StatesFull-TimeSenior
Salary150,000 - 180,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Languages
- Read, write and speak fluent English
- Experience
- Ten or more years of clinical science or clinical development experience
- Required Skills
- Project ManagementGCP
Requirements
- Advanced degree in biomedical science or a health-related field; MD or PhD preferred.
- Ten or more years of clinical science or clinical development experience in medical-device or related industries, academic medical centers or universities, or academic or commercial research organizations.
- 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, and clinical trial design.
- Strong understanding of causal inference and basic and intermediate biostatistics.
- Working knowledge of diagnostic testing accuracy metrics, including sensitivity, specificity, PPV, and NPV.
- Working knowledge of GCP and FDA and EU regulations regarding medical devices and SaMD.
- Strong writing skills and experience writing clinical study reports, conference abstracts, and peer-reviewed manuscripts.
- Experience with US and EU clinical-regulatory documentation preferred, such as 510(k), IDE, PMA, and CER.
- Experience in program management and project oversight, including high-visibility projects.
- Fluent English; able to read, write, speak, and present information to varied audiences.
- Willingness and ability to travel domestically and internationally; travel is anticipated to be less than 30% of work time.
Responsibilities
- Manage project-level scientific aspects of clinical research, including study design, analysis, and evidence dissemination.
- Support development of clinical evidence strategies.
- Develop study designs and protocols for prospective trials supporting market clearance and post-market evidence.
- Create analysis plans and protocols for targeted analysis of existing datasets and real-world evidence.
- Drive analysis and interpretation of prospective clinical data and real-world evidence with data management and biostatistics teams.
- Lead scientific writing and dissemination, including conference abstracts, journal articles, posters, and slides.
- Collaborate with internal and external co-authors, clinical thought leaders, and subject matter experts.
- Support health economics and outcomes research and regulatory teams with clinical-regulatory documentation.
- Monitor study progress and partner with clinical research operations on timely execution, project risks, quality standards, and regulatory requirements.
View Full Description & ApplyYou'll be redirected to the employer's site
