Clinical Trial Manager

Position Summary This is a contract position (initial 8-month term with potential extension). The Contract Clinical Trial Manager (CTM) serves as the sponsor-side operational study lead, responsible for day-to-day execution and oversight of clinical trial activities during study start-up, activation, and enrollment phases. The role acts as an operational interface with CRO partners and internal cross‑functional teams, ensuring timelines, budgets, quality standards, and compliance obligations are met. The CTM manages study governance processes, including risk management, decision logs, meeting cadence, and financial tracking, while supporting TMF oversight and clinical quality system activities. The CTM reports to Senior Clinical Operations leadership and collaborates closely with the CRO, Monitoring Manager, CRAs, Legal/Finance, QA, and external vendors. Job Responsibilities Study Execution & Project Management Lead day‑to‑day operational management of assigned clinical study(s) under the direction of the Sr. Clinical Operations Manager Develop and maintain detailed study timelines and project trackers Coordinate cross‑functional study team meetings and maintain action item logs Maintain and actively manage the study risk log with mitigation plans and decision log; elevate significant risks appropriately Track study milestones to ensure adherence to approved timelines Budget & Financial Oversight Track study budget, accruals, and financial forecasts Support invoice review and reconciliation Coordinate CTA/CTA Amendments in partnership with legal and finance as needed Ensure financial alignment between scope, contracts, and study execution Monitoring & Site Integration Review monitoring reports as required, identify trends, and elevate issues appropriately Conduct site level training as required Quality & Compliance Ensure study activities are conducted in compliance with regulations, GCP, and company SOPs Perform sponsor‑level TMF oversight reviews (in collaboration with CRO) Support development of new clinical processes and SOPs as needed Support inspection readiness efforts through documentation tracking and quality review Ensure essential documents are filed appropriately and timely Upload sponsor quality documents into the Quality Management System (QMS) Prepare routine study status updates and dashboards for internal stakeholders Support preparation of clinical study reports, clinical evaluation reports, and regulatory submission documentation as requested Qualifications & Requirements Bachelor's degree in life sciences or equivalent training/experience Minimum of 7+ years of clinical research experience within medical device, biotechnology, or pharmaceutical industry 3–5 years of clinical trial management or study coordination experience Experience working within a sponsor/CRO hybrid operating model preferred Experience supporting clinical study budgets, accrual forecasting, and vendor oversight required Medical device clinical trial experience strongly preferred Knowledge of FDA regulations, ISO/ICH‑GCP, and applicable clinical research standards Strong understanding of clinical trial lifecycle from study start‑up through close‑out Experience maintaining risk registers, action logs, and project timelines Familiarity with clinical trial budgeting, accrual tracking, and invoice reconciliation Ability to analyze operational metrics and identify trends Strong organizational and documentation skills Excellent written and verbal communication skills Proficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with EDC/TMF systems Ability to manage multiple priorities in a fast‑paced, small‑company environment Demonstrated ability to work independently while escalating appropriately Working Conditions Long periods of sitting or standing at a computer Ability to travel to study sites, investigator meetings, and in‑person meetings as required #J-18808-Ljbffr