Manager, Clinical Trials

Role: Clinical Trials Manager overseeing all phases of complex clinical studies, ensuring compliance with protocols, SOPs, and regulatory standards. Responsibilities include vendor and CRO management, study start-up and close-out, budgeting, monitoring study progress, and training staff. The role involves collaboration with data management, investigative sites, and cross-functional teams to meet timelines, quality, and cost targets. Qualifications: Bachelor's in life sciences with 8+ years in clinical research, at least 4 years in a leadership role managing clinical trials within regulated environments. Experience supporting CROs preferred. Knowledge of FDA regulations, ICH-GCP, and GxP standards essential. Skills include project management, vendor oversight, protocol development, and strong communication. High-Value: Focus on early to late-phase clinical trials, in a regulated setting, supporting biomarker or genomic testing in oncology or women's health. The position is remote within the USA, with no specified travel expectations.