Clinical Trial Manager - CNS

Clinical Trial Manager - CNS The Clinical Trial Manager (CTM) is responsible for managing the clinical and operational activities of assigned clinical studies. This is accomplished by ensuring all projects are completed on-time and on-budget while following all company policies, Standard Operating Procedures (SOPs) and applicable regulatory guidelines. Plan, develop, and follow systems and procedures to ensure optimum compliance in accordance with GCP/ICH guidelines and FDA regulations. Ensure operating quality and efficiency. Essential Duties and Responsibilities Support or lead clinical study activities from start-up through closeout, ensuring adherence to timelines, budget, quality standards, SOPs, and regulatory requirements. Oversee development and maintenance of study documentation including informed consent forms, IRB submissions, project plans, tracking tools, financial worksheets, and regulatory files. Engage with investigative sites during start-up to coordinate CDAs, feasibility assessments, budgets, and CTAs. Manage and maintain the Trial Master File (TMF), ensuring accuracy, completeness, and inspection readiness. Oversee monitoring activities, including review and approval of monitoring visit reports, tracking site issues, data queries, protocol deviations, and ensuring timely resolution. Assign, mentor, and support CRAs; lead team training, provide performance feedback, and ensure ongoing staff compliance with required training. Monitor enrollment trends, operational risks, and study metrics; develop mitigation strategies and escalate issues appropriately. Conduct internal team calls, participate in Sponsor meetings, and serve as key contact for site, CRA, and Sponsor inquiries. Coordinate clinical resource planning, monitoring schedules, and budget oversight related to monitoring activities; support PM with grant administration and invoicing. Participate in development/testing of clinical systems and process improvement initiatives. Perform co‑monitoring visits and, when needed, assume CRA responsibilities. Complete vendor reconciliation and support cross-functional collaboration to ensure data quality. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Supervisory experience preferred Minimum 3 years’ experience in clinical research industry Minimum of 2 years‘ experience as a Clinical Monitor/Clinical Research Associate (CRA) strongly preferred Working knowledge of GCPs, ICH guidelines, FDA and other applicable regulations Specialized knowledge of CNS therapeutic areas Proficiency in Microsoft Word, Excel, Powerpoint and Outlook Proficiency with Teams and Zoom Effective writing and verbal skills, English language Meticulous attention to detail Time management and ability to prioritize Ability to travel 10-20% Department Clinical Operations Role Clinical Trial Manager Locations Remote, US Remote status Fully Remote Employment type Full-time About Cognitive Research Corporation Cognitive Research Corporation (CRC) is a leading full-service contract research organization, specializing exclusively in CNS disorders. Guided by a commitment to urgency, consistency, and accuracy, we help bring new therapies through rigorous testing to FDA approval, ultimately improving patient outcomes.