Clinical Operations Lead
Core
Lead clinical operations for human studies using functional ultrasound imaging and neuromodulation to treat brain disorders.
Role type
Senior Clinical Operations Lead (Clinical Research)
Builds
Clinical study infrastructure, recruitment programs, and partnerships with hospitals/academic centers for neuromodulation trials.
Domain
Clinical Neuroscience / Neuromodulation / Medical Devices
Deliverable
client delivery
Required skills
Human clinical research operations, scientific training (PhD preferred), stakeholder management, regulatory compliance (IRB), study start-up, participant management, document control, safety monitoring, troubleshooting medical devices.
Preferred skills
Neuroscience background, neuroimaging, hospital/academic center partnerships, early-stage medtech/biotech, ICH-GCP, ISO 14155, FDA requirements, QMS, CTMS, eTMF, AE/SAE reporting.
Technologies
Functional ultrasound systems, focused ultrasound neuromodulation devices, clinical trial management systems (CTMS), electronic trial master files (eTMF).
Responsibilities
Partner on clinical strategy and site selection; develop recruitment programs; qualify and onboard clinical partners; design at-home study logistics; lead study start-ups; manage IRB submissions; coordinate participant visits and payments; manage device deployment and technical support; maintain TMF and SOPs; track adverse events.
Seniority
Senior, hands-on IC building infrastructure