Remote Clinical Trial Manager — Neurotech & Brain Health

Cognito Therapeutics, Inc.; Cambridge (MA); Híbrido; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Unlimited PTO

Wellness perks

Virtual medical support

Health, dental, and vision insurance

Descripción de la vacante

Cognito Therapeutics, Inc. is seeking an experienced Clinical Trial Manager to lead our Clinical Operations team and drive the successful execution of clinical studies.

You will manage study plans, timelines, budgets, vendors, and deliverables, ensuring high quality, compliant study execution from planning through close-out. The ideal candidate has strong CTM experience, robust knowledge of GCP and regulatory requirements, and excellent organizational and communication skills.

Formación

• Bachelor degree with 6+ years in clinical operations, including 1-2 years CTM experience.
• Understanding of clinical development strategies and trial designs.
• Understanding of medical and statistical scientific methodology.
• Working knowledge of GCP and regulatory environment; strong ethics.
• Good communication skills; team player.
• Ability to travel up to 15%.

Responsabilidades

• Lead and oversee clinical trial operations per protocols, SOPs, GCP and regulations.
• Develop and manage study plans, timelines, milestones, budgets, and deliverables.
• Oversee clinical site activities: initiation, monitoring, performance management, and close-out.
• Provide oversight of TMF completeness and inspection readiness.
• Oversee CROs and external vendors, manage KPIs and deliverables.
• Lead study tracking, enrollment monitoring, site performance, and key metrics.
• Oversee CTMS activities, ensuring accurate study tracking and action-item resolution.
• Manage assigned study budgets, including forecasting, invoices, reconciliation, and budget risks.
• Oversee study supplies, licenses, laboratory activities, and operational resources.
• Partner with Data Management to support EDC development, data quality, and data deliverables.
• Ensure oversight of study systems, user access, and documentation.
• Oversee DMC operational activities, meeting prep and follow-up on recommendations.
• Proactively identify, assess, and mitigate study risks; escalate major issues as needed.
• Lead cross-functional coordination with sites, CROs, vendors, and internal stakeholders.
• Support protocol development, amendments, and operational changes throughout the lifecycle.
• Drive continuous improvement of Clinical Operations processes, tools, and workflows.
• Oversee setup and management of in-house safety database with regulatory compliance.

Conocimientos

Clinical trial management

GCP knowledge

Regulatory compliance

Vendor management

Budget management

Communication skills

Travel willingness

Educación

Bachelor degree

Herramientas

CTMS

Descripción del empleo

Cognito Therapeutics, Inc. is seeking an experienced Clinical Trial Manager to lead our Clinical Operations team and drive the successful execution of clinical studies.

You will manage study plans, timelines, budgets, vendors, and deliverables, ensuring high quality, compliant study execution from planning through close-out. The ideal candidate has strong CTM experience, robust knowledge of GCP and regulatory requirements, and excellent organizational and communication skills.