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
