Clinical Trial Manager/Senior 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%