Clinical Trial Manager — Neurotherapy & Brain Health

Cognito Therapeutics; Cambridge (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Unlimited PTO

Wellness perks

Virtual medical support

Health, dental, and vision insurance

Job summary

Cognito Therapeutics in Cambridge, MA is seeking an experienced Clinical Trial Manager to lead the execution of our clinical studies. You will oversee study plans, timelines, budgets, vendors, and deliverables, ensuring high-quality, compliant trial operations in collaboration with sites, CROs, and internal teams.

The ideal candidate has strong CTM experience, deep knowledge of GCP and regulatory requirements, excellent communication, and the ability to manage multiple priorities in a fast-paced

Qualifications

• Experience in clinical development strategies and trial designs.
• Knowledge of medical and statistical scientific methodology.
• Familiarity with regulatory environments of medical devices/pharma and strong ethics.
• Good communication skills; team player.
• Ability to travel up to 15%.

Responsibilities

• Lead and oversee clinical trial operations, ensuring compliant and timely execution.
• Develop and manage study plans, timelines, milestones, budgets, and deliverables.
• Oversee site activities including initiation, monitoring, performance management, and close-out.
• Provide TMF completeness and inspection-readiness oversight.
• Oversee CROs and external vendors and manage KPIs and deliverables.
• Lead study tracking and reporting, monitor enrollment and site performance.
• Oversee CTMS activities and action item resolution.
• Manage study budgets, forecasting, invoices, and budget risks.
• Ensure study supplies and lab activities support continuity.
• Collaborate with Data Management for EDC and data deliverables.
• Ensure study systems access and documentation compliance.
• Oversee DMC operational activities and meeting preparation.
• Identify, assess, and mitigate study risks; escalate significant issues.
• Coordinate with sites, CROs, vendors, and stakeholders for timely decisions.
• Support protocol development and study amendments.
• Drive continuous improvement of Clinical Operations processes.
• Oversee setup and management of in-house safety database.

Skills

Clinical trial management

GCP knowledge

Communication

Travel readiness

Education

Bachelor degree in a scientific field

Tools

CTMS

Job description

Cognito Therapeutics in Cambridge, MA is seeking an experienced Clinical Trial Manager to lead the execution of our clinical studies. You will oversee study plans, timelines, budgets, vendors, and deliverables, ensuring high-quality, compliant trial operations in collaboration with sites, CROs, and internal teams.

The ideal candidate has strong CTM experience, deep knowledge of GCP and regulatory requirements, excellent communication, and the ability to manage multiple priorities in a fast-paced