Clinical Trial Manager: Lead Study Delivery & Compliance

Cognitive Research Corporation; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Cognitive Research Corporation seeks a Clinical Trial Manager to lead and oversee clinical studies from start-up to closeout in the United States. You will ensure projects are delivered on time and within budget while complying with GCP/ICH and FDA regulations, and supervise CRAs to maintain TMF integrity and accurate monitoring.

The role requires strong communication, meticulous attention to detail, and travel 10-20%.

Qualifications

• Requires Bachelor's degree or RN in a related field or equivalent
• Minimum 3 years' experience in clinical research
• Minimum 2 years' experience as a Clinical Monitor/CRA preferred
• Knowledge of GCP/ICH guidelines, FDA regulations
• Specialized knowledge of CNS therapeutic areas
• Proficient in Word, Excel, PowerPoint and Outlook
• Proficient with Teams and Zoom
• Strong written and verbal English skills
• Meticulous attention to detail and time management
• Ability to travel 10-20% of time

Responsibilities

• Support or lead clinical study activities from start-up through closeout, ensuring timelines and budget adherence
• Oversee development and maintenance of study documentation
• Coordinate with sites during start-up for CDAs, feasibility, budgets, and CTAs
• Manage Trial Master File (TMF) accuracy and inspection readiness
• Oversee monitoring activities and track site issues and data queries
• Mentor and support CRAs; lead training and ensure compliance
• Monitor enrollment, risks, and study metrics; develop mitigation strategies
• Participate in sponsor meetings and serve as contact for site/CRA/Sponsor inquiries
• Coordinate clinical resource planning and budget oversight for monitoring
• Participate in development/testing of clinical systems and process improvements
• Conduct co-monitoring visits and, when needed, assume CRA duties
• Perform vendor reconciliation and support cross-functional data quality

Skills

Clinical trial management

Team supervision

Regulatory knowledge

GCP/ICH/FDA knowledge

Communication

Time management

Travel readiness

Education

Bachelor's degree

RN (Registered Nurse)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Teams

Zoom

Job description

Cognitive Research Corporation seeks a Clinical Trial Manager to lead and oversee clinical studies from start-up to closeout in the United States. You will ensure projects are delivered on time and within budget while complying with GCP/ICH and FDA regulations, and supervise CRAs to maintain TMF integrity and accurate monitoring.

The role requires strong communication, meticulous attention to detail, and travel 10-20%.