Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Independently manage assigned clinical trial activities in compliance with GCP and regulations.
Oversee essential study documentation, TMF completeness, and study trackers.
Manage vendors, CTMS activities, and cross-functional coordination to ensure compliant study execution.
Cognito Therapeutics is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, including an investigational therapy for Alzheimer's disease. The company is an interdisciplinary team united by a shared purpose of protecting and progressing the human ability to think, learn and remember.