The Sr. Manager, Clinical Site Development leads the identification, activation, and performance support of clinical sites for the company's IDE and post-market programs. This role involves building strong relationships with investigators and clinical staff to ensure successful study execution and enrollment objectives.
The Sr. Clinical Research Associate will manage and monitor clinical study activities at US and international sites to ensure compliance with FDA and ICH-GCP standards. Responsibilities include overseeing patient recruitment, data integrity, regulatory document review, and providing clinical support for study execution.
The Sr. Clinical Research Associate manages and monitors clinical trial activities, including site start-up, patient recruitment, and data quality assurance. They ensure all study procedures comply with FDA regulations and ICH-GCP guidelines while providing procedural support to research sites.