(East Coast) 100% Remote
May Health, formerly AblaCare, is a clinical-stage medical device company committed to developing treatment options for women living with PCOS. The company is currently investigating its Ovarian Rebalancing™ treatment in clinical studies; Ovarian Rebalancing is a novel approach to PCOS-related fertility that has the potential to be a safe, straightforward option for activating natural ovulation. May Health is led by a team of serial medtech and women's health entrepreneurs and executives with extensive experience in product development, validation, and launch. The company has raised €10M in a Series A led by Sofinnova Partners and was founded in 2017 by the firm's medtech acceleration team, Sofinnova MD Start. May Health is headquartered in Paris, France. For more information, visit www.mayhealth.com.
Position Summary
The Clinical Specialist is responsible for providing technical case support and physician training within an investigational medical device clinical trial.
Responsibilities
Major Responsibilities:
- Educate physicians on device handling, procedure completion and troubleshooting techniques related to the equipment required for the device
- Coordinate one-on-one training sessions and in-service education programs in the hospital environment
- Provide medical staff with clinical instructions to support the full continuum of patient care
- Serve as the designated expert on May Health products by sharing your knowledge and training hospital staff
- Provide on-site, real-time guidance during clinical cases and proactively prepare contingency plans to address unforeseen occurrences
- Document procedural case observations for regulatory requirements and ongoing continuous improvement
- Collaborate with product development teams to provide feedback on device features and new device development
- Support site research personnel and physicians in conducting device accountability in accordance with federal regulations
- Proactively engage with site in optimizing their engagement and experience with the trial and with May Health Collaborative mindset in providing feedback to cross-functional teams to support the study and future commercialization
Compliance & Legal Responsibilities:
- Maintaining the highest standards of ethics in all circumstances
- Ensuring respect of Good Clinical Practices and General Data Protection Regulation Ensuring compliance with the Company quality system and all applicable guidance, standards and regulations.
Position Requirements
Necessary skills and experience:
- A minimum of 4 years of relevant medical device clinical research experience
- Experience with therapeutic and/or implantable devices
- Formal education and clinical experience in one or more of the following specialties: Nursing (RN/BSN/MSN), Physician Assistant (PA-C), Biomedical engineering, or Ultrasound Technician
- A willingness to travel frequently within the United States (~60%)
Preferred experience:
- Women’s Health, egg retrieval procedures
- Clinical engineering experience from industry-related positions that support clinical development and clinical case support
