Clinical Trial Manager - Neuroscience

Company Overview:
Cognitive Research Corporation (CRC) is a leading clinical research organization specializing in Central Nervous System (CNS) research. Since our founding in 2006, we have been dedicated to supporting our customers through all phases of clinical trials, contributing to the development and approval of innovative treatments. We pride ourselves on fostering a supportive and dynamic workplace culture that values professional growth and inclusivity.

Position Overview:
The Clinical Trial Manager 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.

Key Responsibilities:

• Responsible for overall clinical study activities: on-time, on-budget completion of clinical projects within quality specifications.
• Assists with the development, modification, and execution of company policiesthat affect clinical operations.
• Works across functional teams and assists with coordination of resources to ensure clinical oversight of data quality.
• Interact with senior management on issues concerning functional areas or clients.
• Implements new company initiatives regarding process improvement to new technology related to clinical research within their staff limits.
• Responsible for ongoing analysis of enrollment activities/trends and escalation/mitigation to PM/Sponsor as appropriate. Works with PM to develop strategic and tactical plans for ensuring enrollment targets are met.
• Responsible for assuring the quality and timeliness of the clinical monitoring deliverables and for identifying and mitigating risks. Conducts project co-monitoring visits and team training to assure the quality of the clinical monitoring deliverables and for identifying and mitigating risks.
• Develops project-specific training materials for team.
• Provides project specific performance feedback to CRA team, PM and Line Management.
• Serves as site and CRA contact for protocol clarifications and subject enrollment.
• Serves as Sponsor contact for monitoring/site issues.
• Responsible for coordination and management of the clinical monitoring budget and scope of work for monitoring activities.
• Assists the PM with coordination and management of grant administration and project invoicing.
• Reviews and approves weekly time and expense reports for CRAs
• Monitors and plans for resolution of data backlog by working with clinical management.
• Performs other duties as assigned

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

Why Join CRC?
At CRC, we believe in the power of collaboration and the importance of fostering an environment that allows our employees to grow and thrive. We offer competitive compensation, comprehensive benefits, and opportunities for professional development. Join us and be a part of a team dedicated to advancing medical science and improving patient outcomes.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Education:

• Bachelor's (Preferred)

Experience:

• Clinical trials management: 1 year (Preferred)

Work Location: Remote