Clinical Trial Manager

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

This is a rare opportunity to join a team that is bringing an entirely new category of brain health to the world. At Cognito, we are developing therapies designed to promote dignity, clarity, and coherence in the lives they touch.

Cognito is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, designed to work with the brain's own activity and biology. Born from pioneering neuroscience research at MIT, Cognito brings together neuroscience, engineering, medicine and technology to translate breakthroughs in brain science into practical therapies designed for everyday life.

Our first therapeutic application, Spectris AD, is an investigational, prescription, at-home therapy for Alzheimer’s disease. With our pivotal HOPE study now complete, Cognito is entering an important new phase as we advance Spectris AD toward regulatory review, prepare for potential commercialization and continue exploring the broader potential of our science across neurological health.

We are building an interdisciplinary team united by a shared purpose: protecting and progressing the human ability to think, learn and remember. For innovators who want to work at the intersection of breakthrough science, technology and human health, Cognito offers the chance to help shape what comes next.

About the Job

We are seeking an experienced, highly organized, and proactive Clinical Trial Manager (CTM) to join our Clinical Operations team and lead the successful execution of our clinical studies. In this role, the Clinical Trial Manager will oversee clinical trial operations, managing study plans, timelines, budgets, vendors, and key deliverables to ensure efficient, high-quality, and compliant study execution. Working closely with cross-functional teams, clinical sites, CROs, and external partners, the CTM will provide operational leadership, proactively identify and mitigate risks, resolve challenges, and drive study activities from planning through close-out. This is a hands-on leadership opportunity with meaningful ownership of clinical trial operations and accountability for achieving study objectives.

The ideal candidate thrives in a dynamic, fast-paced environment and brings a proactive, collaborative, and solutions-oriented approach to their work. They possess strong clinical trial management experience, excellent organizational and communication skills, and a thorough understanding of Good Clinical Practice (GCP), applicable regulatory requirements, and clinical research operations. They demonstrate sound judgment, effective decision-making, and the ability to manage competing priorities, lead cross-functional teams, and hold vendors and stakeholders accountable for deliverables. Above all, they are motivated by the opportunity to contribute to innovative therapies with the potential to make a meaningful difference in patients’ lives.

Responsibilities

You will be responsible for:

• Lead and oversee clinical trial operations, ensuring timely, high-quality execution in compliance with study protocols, SOPs, GCP, and applicable regulations.
• Develop and manage study plans, timelines, milestones, budgets, and deliverables, ensuring alignment with overall study objectives.
• Oversee clinical site activities, including site initiation, monitoring, performance management, and close-out.
• Provide oversight of essential study documentation, Trial Master File (TMF) completeness, and ongoing inspection readiness.
• Oversee CROs and external vendors, managing performance, contractual deliverables, KPIs, and resolution of operational issues.
• Lead study tracking and reporting activities, monitoring enrollment, recruitment, site performance, and key study metrics.
• Oversee Clinical Trial Management System (CTMS) activities, ensuring accurate study tracking, monitoring documentation, and timely resolution of action items.
• Manage assigned study budgets, including expense forecasting, vendor invoices, financial reconciliation, and identification of budget risks.
• Oversee study supplies, clinical assessment licenses, laboratory activities, and other operational resources to ensure study continuity.
• Partner with Data Management to support EDC development, data quality, query resolution, database lock, and study data deliverables.
• Ensure appropriate oversight of study systems, user access, and documentation in accordance with applicable requirements.
• Oversee Data Monitoring Committee (DMC) operational activities, including meeting planning, preparation of materials, documentation, and follow-up of recommendations.
• Proactively identify, assess, and mitigate study risks, independently resolving operational challenges and escalating significant issues as appropriate.
• Lead cross-functional coordination with clinical sites, CROs, vendors, and internal stakeholders to drive timely decisions and study deliverables.
• Support protocol development, study amendments, and implementation of operational changes throughout the study lifecycle.
• Drive continuous improvement of Clinical Operations processes, tools, and workflows to enhance efficiency, quality, and compliance.
• Oversee the setup, implementation, and ongoing management of the in-house clinical safety database, ensuring accurate safety data collection, reconciliation, and compliance with study procedures and applicable regulatory requirements.

Qualifications

• Bachelor degree (B.A./B.S.) with minimum of 6+ of relevant work experience with 1-2 years of CTM work experience
• Understanding of clinical development strategies and trial designs
• Understanding of medical and statistical scientific methodology
• Working knowledge of GCP, understanding of the regulatory environment of the medical device/ pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics
• Good communication skills; team player
• Ability to travel up to 15%

Competitive Benefits

Taking care of our own is one of our highest priorities. That's why we offer benefits including unlimited PTO, wellness perks, virtual medical support, and health, dental, and vision insurance.

Physical Requirements & Work Environment

• This role is primarily performed in an office or home-office setting. Essential physical requirements include the ability to work at a computer for extended periods, communicating effectively in written and verbal formats, and participate in video and in-person meetings.
• Occasional travel to partner sites may be required. For remote roles, occasional travel to Cognito's Cambridge, MA office may also be required.

Cognito Therapeutics is committed to providing reasonable accommodation for qualified individuals with disabilities throughout the application and hiring process. If you require accommodation, please contact us at [e-mail].

Cognito Therapeutics is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and make employment decisions based on qualifications, merit, business needs, and job requirements. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

All applicants must be legally authorized to work in the United States.