Jobs at Clinilabs, LLC

Prepare, operate, and maintain polysomnography and physiological monitoring equipment for clinical and research studies; collect and enter subject data; perform vital signs, ECG, venipuncture/phlebotomy, psychometric assessments, and ensure protocol compliance and documentation per GCP and regulatory guidelines.

Leads Clinilabs’ quality assurance and regulatory compliance strategy for clinical research activities. Oversees quality systems, GCP compliance, computer system validation, audits, vendor qualification, quality agreements, document control, training, inspection readiness, and interactions with FDA and other regulatory bodies. Develops quality and regulatory staff, establishes compliance standards, monitors system effectiveness, and drives process harmonization, improvement, and organizational performance across internal and external clinical trial activities.

Leads global or regional clinical trial study start-up through final site activation. Oversees regulatory, EC/IRB, CTA, CTIS, and EU CTR submissions; coordinates specialists and cross-functional teams; manages timelines, risks, resources, quality, documentation, and customer updates. Provides regulatory expertise, supports audits, SOP development, business development, and team mentoring without direct line management. Requires advanced CTIS expertise, EU CTR knowledge, and experience in pharma, biotech, or CRO environments.

Leads global, multi-regional CNS clinical trials from protocol concept through final study report. Manages project plans, budgets, timelines, risks, vendors, resources, site activation, monitoring oversight, regulatory coordination, data quality, safety tracking, and study closeout. Serves as the primary sponsor contact, ensures ICH-GCP and regulatory compliance, supports proposals and bid defenses, and drives process improvements. Global travel may be required based on study needs.