- Execute on Anteris' scientific objectives within Anteris-sponsored clinical studies.
- Lead (or support as needed) protocol development, revisions, submission, and approval, including consensus building with study steering committee and principal investigators.
- Lead clinical research to support Anteris's mission as the science company.
- Support clinical patient enrolment efforts.
- Serve as Scientific Lead on Anteris sponsored clinical studies.
- Be the point person for scientific questions during execution of these clinical studies.
- Execute publication/presentation, charter development for clinical studies.
- Responsible for scientific content for all trial related documents
- Develop annual and final report content development, coordination of content from various stakeholders.
- Perform data analysis and interpretation.
- Develop maintain and review periodical study reports. Review for outliers, ranges, potentially problematic data, identify and communicate root causes from input error to inadequate field edits, and suggest practical solutions, thereby documents data observations, and follow pre-established processes and procedures.
- Conduct literature review and clinical data to support regulatory submissions and CERs.
- May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.
- Lead Steering committee meetings and Scientific lead on Investigator/Research coordinator meetings.
- Establish relationships with study sites, investigators, and support identification of new investigators.
- Present balanced and accurate interpretation of the data
- Provide clinical training/education cross functionally.
- Advanced degree in life sciences required; MD or PhD preferred.
- 3+ years of Clinical Science / Research experience in Cardiology / Cardiovascular / Structural Heart space or Clinical Science / Research experience in Med Devices.
- Med Device TAVR Clinical Research experience strongly preferred.
- Experience with imaging modalities (echo, CT, CMR) reads and interpretation
- Experience with scientific contribution to large multi-center clinical trials
- Proficiency in Med terminology, medical writing, experience with following ICMJE guidelines
- Good understanding of Biostatistics; ability to use statistical programs such as Matlab, SPSS or SAS a strong plus.
- Knowledge of healthcare ethics, compliance regulations
- Strong work ethic, self-motivation, team player, excellent English written and oral communication skills and strong interpersonal skills.
- Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
- Collaborative and dynamic work environment with a culture of innovation and excellence.
- 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
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Clinical Research Scientist - Osseo, United States - Anteris Tech
Description
Job Description
Job DescriptionSalary:Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the world's most durable heart valve. We are a medical device start-up with offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia.
The Clinical Research Scientist will support and guide clinical studies (US and OUS) within the structural heart product space at Anteris Technologies. This individual will deliver sound clinical evidence generation to drive better patient outcomes with the use of our inventions.
This role will be one of the first clinical research positions on a growing Clinical and Regulatory team and will require the utmost attention to detail to achieve our program goals in collaboration with a cross-functional global team. This is a highly visible role, making a substantial contribution to Anteris Technologies
Main Responsibilities:
Preferred Location: Boston, MA
Optional Location: Minneapolis, MN
Required Skills, Knowledge, Experience & Qualifications:
Preferred Skills, Knowledge, Experience & Qualifications:
What We Offer:
Health and Wellness Offerings:
Note: We may require proof of COVID-19 vaccination to comply with the state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.
