Clinical Trial Manager: Lead On-Time, On-Budget Studies

Cognitive Research Corporation; United States; Remote; USD 95,000 - 135,000; Full time

Job summary

Cognitive Research Corporation is seeking a Clinical Trial Manager to oversee clinical studies from initiation to closeout, ensuring timelines and budgets are met while maintaining GCP compliance. You will coordinate site startup activities, manage TMF, monitor visits, and mentor CRAs, with travel up to 20%.

The role requires strong regulatory knowledge, CNS experience, and proficiency in MS Office and virtual collaboration tools. Strong writing and communication skills are essential.

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%.

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 escalation 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.

Skills

GCP/ICH guidelines

FDA regulations

CNS therapeutic areas

Supervisory experience

CRA/Monitor experience

English proficiency

Teams/Zoom proficiency

Education

Bachelor’s degree or RN

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Teams

Zoom

Job description

Cognitive Research Corporation is seeking a Clinical Trial Manager to oversee clinical studies from initiation to closeout, ensuring timelines and budgets are met while maintaining GCP compliance. You will coordinate site startup activities, manage TMF, monitor visits, and mentor CRAs, with travel up to 20%.

The role requires strong regulatory knowledge, CNS experience, and proficiency in MS Office and virtual collaboration tools. Strong writing and communication skills are essential.