[Remote] Sr Clinical Research Scientist
Note: The job is a remote job and is open to candidates in USA. Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. The Senior Clinical Research Scientist will provide scientific, clinical, and operational expertise to support global clinical studies and ensure scientific objectives are achieved, working cross-functionally on the design, execution, and communication of clinical trial data.
Responsibilities
- Represent Anteris as an industry leader within scientific, clinical research, and industry organizations
- Serve as a Scientific Lead and Subject Matter Expert for Anteris-sponsored clinical studies
- Partner cross-functionally to support the scientific objectives of Anteris-sponsored clinical studies and advance the company’s mission as a science-driven organization
- Lead execution of the subject selection process to ensure accurate and timely review of subject eligibility criteria, with oversight from clinical leadership
- Oversee external vendor performance and drive effective cross-functional collaboration
- Contribute to clinical trial design, protocol development, protocol revisions, and reports supporting regulatory submissions, with guidance from clinical leadership
- Participate in publication planning activities in collaboration with cross-functional stakeholders
- Support charter development for clinical studies in partnership with external vendors and study leadership, with oversight from clinical leadership
- Perform data analysis and interpretation in collaboration with external biostatisticians and internal data management teams
- Deliver timely study updates to clinical and cross-functional leadership through clear, well-structured presentations and data summaries
- Develop, maintain, and review clinical study reports and related documentation
- Contribute to root cause analyses, corrective and preventive actions, and effectiveness monitoring, with oversight from clinical leadership
- Collaborate with internal and external stakeholders, including study sites, vendors, and committees, to support clinical trial objectives and appropriately escalate issues when needed
- Build and maintain strong relationships with study investigators and key opinion leaders
- Contribute to Medical Legal Review (MLR) activities as a clinical subject matter expert for external data releases, ensuring scientific accuracy and appropriate clinical interpretation prior to publication or disclosure
- Assist in compiling clinical documentation and data for regulatory submissions
- Provide cross-functional clinical training and education support
Skills
- Advanced degree in Life Sciences required; MD or PhD preferred
- 5+ years of Clinical Science or Clinical Research experience within cardiology, cardiovascular, or medical device environments
- Experience contributing scientifically to medical device clinical trials
- Proficiency in medical terminology and medical writing, including experience working within ICMJE guidelines
- Knowledge of healthcare ethics and compliance regulations
- Strong work ethic, self-motivation, collaboration skills, and excellent written and verbal English communication skills
- TAVR clinical research experience strongly preferred
- Extensive clinical or scientific experience with advanced training in research, study design, and statistics (MSN, PhD, MS, or equivalent)
- Experience with imaging modalities, including echocardiography, CT, and CMR interpretation
- Experience supporting international, multi-center, randomized clinical trials
- Experience with statistical software programs such as Matlab, SPSS, or SAS is a strong plus
Benefits
- Competitive compensation package, including salary, performance-based bonuses, and stock options.
- Career development opportunities and a chance to be part of a growing company that values its employees.
- Medical, Dental, and Vision Plans
- Flexible Spending Account (FSA)
- 401k + Company Match
- Life, AD&D, Short-Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Stock Option Plan
- Paid Holidays & Vacation
- Employee Assistance Program
- Inclusive Team Environment
Company Overview
Company H1B Sponsorship