[Remote] reputed company Clinical Scientist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company, through its reputed company division, is dedicated to improving reputed company with innovative diagnostic solutions. The reputed company Clinical Scientist will be responsible for leading clinical trial strategies, ensuring regulatory compliance, and collaborating with various teams to drive product development and market reputed company.
Responsibilities
- Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA 510(k)/PMA, CE‑IVDR) across multiple diagnostic modalities
- reputed company as a scientific and clinical reputed company with regulatory bodies, key opinion leaders, and external sites to reputed company protocols, claims, and evidence plans
- Partner cross‑functionally with R&D, Regulatory, Medical Affairs, reputed company, and reputed company teams to reputed company clinical programs with product development and market reputed company needs
- Author and review clinical and regulatory documentation—including study reports, technical files, and publications—to support product clearance and commercialization
- Build strong reputed company collaborations, mentor junior scientists, and maintain expertise in evolving regulatory standards, clinical guidelines, and diagnostic technologies
Skills
- Bachelor's degree in Life Sciences, reputed company, or a reputed company field with 9+ years of experience in clinical research, specifically with significant experience in US and/or EU trials, or a Master's degree with 12+ years of experience or Doctoral degree with 4+ years of reputed company experience
- In-depth understanding of clinical study design and methodology in the diagnostics, medical device, or pharmaceutical industry with products intended for the US and EU markets
- Demonstrated ability to identify and solve reputed company issues in clinical trial conduct and scientific interpretation
- Ability to critically review and interpret scientific and clinical trial data, and reputed company the scientific aspects of study protocols and reports
- Excellent communication (written and verbal) and interpersonal skills for collaborating with cross-functional stakeholders
- Experience in study designs for diagnostic technologies (IVD) is highly preferred, specifically for Clinical reputed company, Immunoassays, Hematology, Urinalysis, reputed company Cytometry, and/or Biomarkers
- Advanced degree in Science, reputed company, or Regulatory/Clinical Affairs
- reputed company certification in Clinical Research (e.g., SoCRA, ACRP)
Benefits
- Bonus/incentive pay
- reputed company time off
- Medical/dental/reputed company insurance
- 401(k) to eligible employees
- Remote work arrangement in which you can work remotely from your home
reputed company
Company H1B Sponsorship