Senior Clinical Research Scientist

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Act as a representative for Anteris, establishing its presence as a leader in scientific, clinical research, and industry organizations.

• Function as the Scientific Lead and Subject Matter Expert for clinical studies sponsored by Anteris.

• Collaborate across various functions to advance the scientific goals of clinical studies.

• Direct the execution of the subject selection process and assess subject eligibility criteria.

• Supervise the performance of external vendors and facilitate cross-functional teamwork.

• Contribute to the design of clinical trials, the development and revision of protocols, and regulatory submission documents.

• Engage in publication planning alongside cross-functional stakeholders.

• Aid in the development of charters for clinical studies in partnership with external vendors and study leadership.

• Conduct data analysis and interpretation in collaboration with external biostatisticians and internal data management teams.

• Present study updates through presentations and data summaries.

• Create, maintain, and review clinical study reports and associated documentation.

• Participate in root cause analyses, corrective and preventive action plans, and effectiveness monitoring.

• Work with study sites, vendors, committees, and other stakeholders, escalating issues when necessary.

• Establish and nurture relationships with study investigators and key opinion leaders.

• Engage in Medical Legal Review activities related to external data releases.

• Assist in gathering clinical documentation and data for regulatory submissions.

• Provide support for cross-functional clinical training and education initiatives.

⛳️ Requirements

• An advanced degree in Life Sciences is required; an MD or PhD is preferred.

• A minimum of 5 years of experience in Clinical Science or Clinical Research within cardiology, cardiovascular, or medical device settings.

• Proven experience in contributing scientifically to clinical trials for medical devices.

• Familiarity with medical terminology and medical writing, including experience adhering to ICMJE guidelines.

• Understanding of healthcare ethics and compliance regulations.

• A strong work ethic, self-motivation, collaborative skills, and exceptional written and verbal communication abilities in English.

• Experience in TAVR clinical research is highly preferred.

• Extensive clinical or scientific background with advanced training in research, study design, and statistics (MSN, PhD, MS, or equivalent) is preferred.

• Experience with imaging modalities, such as echocardiography, CT, and CMR interpretation, is preferred.

• Background in supporting international, multi-center, randomized clinical trials is preferred.

• Familiarity with statistical software programs such as Matlab, SPSS, or SAS is a significant advantage.

🏝️ Benefits

• Competitive compensation package that includes performance-based bonuses and stock options.

• Opportunities for career development.

• Comprehensive Medical, Dental, and Vision Plans.

• Flexible Spending Account (FSA).

• 401k plan with Company Match.

• Life Insurance, AD&D, Short-Term and Long-Term Disability Insurance.

• Eligibility for a bonus plan.

• Employee Stock Option Plan.

• Paid Holidays and Vacation.

• Employee Assistance Program.

• A welcoming and inclusive team environment.

• An opportunity to make a meaningful impact in the healthcare sector.

• A collaborative and dynamic workplace culture that fosters innovation and excellence.