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%
Bachelor’s degree or RN, 3+ years in clinical research, and preferably 2+ years as a clinical monitor or CRA. Requires GCP, ICH, FDA, CNS knowledge, English proficiency, and supervisory experience preferred.
Key Responsibilities
- managing studies
- overseeing monitoring
- mentoring CRAs
Skills & Tools
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams, Zoom
Job Details
- Category: Research and Development (R&D)
- Seniority: Mid Level
- Commitment: Full Time
- Workplace: Remote — United States
- Languages: English
About Cognitive Research Corporation
A contract research organization specializing in clinical studies for central nervous system disorders. — Industry: Research and Development