Clinical Trial Manager - CNS

About the role

The Clinical Trial Manager (CTM) manages the clinical and operational activities of assigned clinical studies, ensuring projects are completed on-time, on-budget, and in compliance with company policies, Standard Operating Procedures (SOPs), and applicable regulatory guidelines. The role involves planning, developing, and implementing systems to ensure optimum compliance with GCP/ICH guidelines and FDA regulations while maintaining operational quality and efficiency.

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.

Requirements

• 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 the 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 in English.
• Meticulous attention to detail.
• Strong time management and ability to prioritize.
• Ability to travel 10-20%.