Clinical Trials Manager (CTM)

Position Summary Experienced clinical operations professional responsible for managing biomarker clinical trials and in vitro diagnostic (IVD) kit studies from study start-up through close-out. Ensures studies are delivered on time, within budget and in compliance with ICH-GCP and FDA requirements, generating high-quality clinical evidence to support regulatory submissions and market access. US-based, remote position. Responsibilities and Activities: Study Planning and Start-up Plan and lead the operational execution of biomarker clinical trials and IVD kit clinical performance studies, from protocol development through database lock and clinical study report. Provide operational input into protocol design, sample handling workflows, and statistical planning to ensure feasibility and regulatory alignment. Contribute to and review study documents, including protocols, informed consent forms, CRFs/eCRFs, monitoring plans and study budgets and timelines. Lead site feasibility, selection and qualification; manage clinical trial agreements, site budgets and IRB/ethics submissions. Planning and oversight of the study from GCP point of view (e.g. clinical trial management, establishing project management in response to study risk, site management plans and associated documentation) Study Execution and Oversight Manage CROs and other vendors; oversee scope, deliverables, performance and invoices. Oversee site monitoring activities and review monitoring reports; drive timely resolutio