Clinical & Product Management Associate

With two clinical studies underway, and a large randomized clinical trial planned for the near future, Sonavex is looking for a capable problem solver to support both on-site clinical study activities and ongoing product improvements. As a Clinical & Product Management Associate, the candidate will need to learn the ins and outs of the EchoMark and EchoSure products, relevant procedures, study protocols, and site management. The individual will be responsible for the successful launch of trial sites, including training users and study personnel, and providing technical product support. The successful candidate will need to be a product specialist who can effectively communicate with our end users, as well as the Sonavex engineering team. As one of the few employees with direct user contact, the associate will be responsible for identifying pain points and helping to guide product improvements and new features. The associate will also support usability testing, user validations, and documentation as a part of the medical device development process.

–      User Training: Train physicians, nurses, research coordinators and other healthcare personnel on the EchoMark and EchoSure devices. In support of this, the associate will also need to work with product and business teams to develop training materials, such as guides, presentations, and one-pagers.

–      Technical Support: Provide on-site and remote support to users including proctoring the use of the product and troubleshooting any technical issues.

–      Study Logistics & Operations: Coordinate with clinical teams across sites regarding patient follow-up schedules, product support, resupply of materials, and any other operational requirements. The associate’s goal is to help the clinical trial sites run a smooth and seamless trial.

–      Data Management: Assist with clinical data management and analysis to support FDA submissions and engineering endeavors.

–      Product Development Support: Assist with product development activities including user needs and requirements definition, usability and validation test design and execution, and documentation per FDA requirements.

–      Other Tasks and Projects: As a startup, there is always a need to figure things out as they come up. Be prepared and willing to jump in on time sensitive tasks as needed.

–      Comfortable working in medical settings, including operating rooms, post-op areas and clinics.

–      Demonstrates strong communication skills, both in-person and in writing. Must be able to convey complex technical concepts to lay users.

–      Technically proficient – will need to become a product specialist with our implant and ultrasound system and communicate with the product team in a detailed manner. Engineering or life science backgrounds preferred.

–      Detail oriented and capable of juggling many tasks and responsibilities.

Requirements & Expectations

–      While travel will fluctuate, candidates should expect frequent travel, up to 50%. Clinical schedules may require non-business day travel.

–      This role offers flexibility to work in-person at the Baltimore office a few days a week and remotely the remaining days. The expectation of how many days are spent in the office is subject to travel requirements and manager discretion.

Applicants must be able to lift 35 lbs.