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 resolution of issues and protocol deviations. Track enrollment, milestones, budget and risks; implement mitigation plans to keep studies on schedule. Own study budgets, including forecasting, internal accrual tracking, and change-order management. Lead financial oversight of CRO and vendor contracts, including negotiation of amendments. Ensure data quality through data review, query resolution and database lock in partnership with data management and biostatistics. Maintain a complete, audit-ready Trial Master File (TMF) and manage deviations and CAPAs. Establish and lead CRO governance meetings (e.g., operational reviews, KPIs, quality reviews). Ensure CRO adherence to KPIs, quality metrics, and contractual obligations. Drive escalation pathways and corrective actions when CRO performance deviates. Regulatory and Quality Ensure studies comply with ICH-GCP E6, applicable FDA regulations (21 CFR Parts 50, 56, 809 and 812), ISO 20916 and company SOPs. Support FDA interactions and submissions (e.g., Pre-Submissions/Q-Subs, IDE, 510(k), De Novo, PMA) by providing clinical study documentation and responses to questions. Contribute to the development and continuous improvement of clinical operations SOPs and processes. Implement and maintain risk-based monitoring strategies and quality oversight plans. Lead risk assessments and ensure mitigation plans are documented and executed. Partner with QA to prepare for audits and inspections; lead operational readiness activities. Cross-functional Collaboration Serve as the primary operational contact for investigators, site staff, CROs and vendors. Partner with medical affairs, regulatory affairs and quality teams to align study execution with company objectives. Provide regular study status updates, metrics and risk assessments to management. Core Competencies and necessary Skills needed: Strong working knowledge of ICH-GCP and FDA regulations for IVD and medical device clinical studies (21 CFR Parts 50, 56, 809, 812) and ISO 20916; familiarity with HIPAA. Proven clinical project management skills: planning, budgeting, risk management and delivery of multi-site studies. ISO 14155 working knowledge and competencies. Experience managing CROs and vendors, including contract and budget negotiation. Proficiency with CTMS, EDC, eTMF systems and MS Office. Highly organized and detail-oriented. Excellent written and verbal communication skills; able to work independently and collaborate effectively in a remote, international team. Willingness to travel to clinical sites and meetings as needed (approximately 20–25%) Education and Experience Needed: Bachelor’s degree in life sciences, nursing or a related field; advanced degree is a plus. 6+ years of clinical research experience in the diagnostics, medical device, biotech or pharmaceutical industry, including independent management of multi-site clinical studies. Experience with biomarker studies preferred; oncology or urology experience is an advantage. Experience with IVD kit clinical performance studies supporting FDA submissions (e.g., 510(k), De Novo, PMA) preferred. Demonstrated experience managing CROs and clinical sites. Clinical research certification (e.g., ACRP CCRA/CCRC or SOCRA CCRP) is a plus. Based in the United States; remote position.