3Aware is looking for a Principal Clinical Scientist to provide leadership and scientific expertise to customer projects. This position will develop relationships with Medical Device manufacturers (MedTech) to help ensure success with their RWD studies within the 3Aware platform.

3Aware supports immediate access to real-world clinical data for medical device manufacturers in a self-administered platform.

MedTech Clinical and Regulatory teams spend exorbitant time and money on real-world data collection to support keeping devices on the market. Traditionally with a host of patchwork solutions, 3Aware provides a solution to meet their clinical data needs reliably, quickly, and affordably. The 3Aware solution provides immediate access to real-world data for device encounters, the ability to Analyze the data for inclusion/ exclusion for PMCF reporting, and Alerts to the safety and performance of devices.

Our solution saves Medtech time and money spent on clinical data acquisition for Post Market Surveillance.

What you will be doing:

• Work directly with MedTech teams to understand project needs
• Review and provide input to clinical project designs and facilitate the transition of the project from the Sales team
• Work cross-functionally to determine the feasibility of success for customer projects using the 3Aware platform
• Coordinate and present key information to customers including, but not limited to, data and patient summaries
• Provide technical and scientific support/guidance for a specific project and train customers on the use of the 3Aware platform
• Lead in the analysis, interpretation, and presentation of clinical data
• Maintain effective communication with cross functional teams and stakeholders
• Track on emerging technologies and US/EU medical device and data privacy regulations

 Your skills & experience:

• Advanced degree in Life Sciences or Engineering required, PhD preferred  
• At least 2 years of experience in the design and conduct of clinical studies with medical devices
• At least 10 years of experience in the medical device industry with an understanding of US and EU regulatory requirements
• Proven ability to exercise sound judgment in independent decision-making
• Working knowledge of the regulatory authorities and other regulatory requirements that may impact global clinical studies
• Willingness and capability to handle multiple projects and responsibilities
• Excellent communication skills
• Ability to present a professional and personable character in all interactions
• Experience in writing study protocols and reports
• Knowledge of MedTech industry, Post-Market Surveillance, and Post-Market Clinical Follow-up

 Why work with us?

• Unlimited PTO, remote friendly and flexible hours
• Paid Medical & Parental Leave
• 401k Matching
• Career planning, mentorships and professional development
• A space to be innovative and collaborative with your peers
• A team that supports each other challenges each other and wants to impact the industry significantly
• Stock Options
• Volunteer Opportunities
• Wellness Programs

Compliance Training

All of our employees are responsible for adhering to federal and state privacy regulations. You will be required to Complete annual regulatory training and certification as required for the Healthcare Insurance Portability and Accountability Act (HIPAA) and other applicable regulations and policies as determined by 3Aware.

 3Aware is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations during the application process are available upon request.