This position will support the planning and implementation of clinical studies and the associated medical device training and operation for development and study of the Pulse Tx technology for dermatology applications. The position will also oversee the use of the device for melanoma applications and other research projects in its early stages.
- Oversees device logistics and operations for the use of the Pulse Tx device for dermatology, oncology and veterinary applications
- Planning and implementing of multi-center studies of clinical effects on skin lesions, with planned future studies for other non-skin tumor targets.
- Clinical trials with a medical device require oversight of device operation of clinical study personnel for investigator sites, device data log monitoring, occasional troubleshooting of software and hardware operations.
- Limited responsibility for overseeing clinical data collection of designated clinical study site personnel.
- Establish and maintain high quality relationships with investigators and their staff as part of overall relationship management process with key scientists and opinion leaders.
- Integrate data management as needed with planned data analysis of the clinical and scientific team
- Assist with development of product labeling, translation, and investigator brochures for clinical studies.
- Develop and/or maintain processes, procedures, and work instructions for system usage and train/monitor users accordingly for adherence to device operation instructions and study protocol requirements.
- Ensure that NCMR and CAPA are appropriately generated, documented, and closed in a timely fashion as defined in established procedure.
- Support internal audits and other regulatory compliant activities as requested
· Carry out responsibilities in accordance with the organization’s policies and applicable laws.
· Support the Pulse Biosciences Quality Policy and Quality System.
- Requires at least 5+ years medical device experience
- BA/BS degree or equivalent
- Demonstrated track record for supervising the training for and use of a medical device in a clinical trial with a protocol approved by an IRB or similar oversight entity
- Ability to travel as needed