Clinical Trial Manager

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, people-focused, and technically inclined Clinical Support Manager to lead the Clinical Support team within Clinical Operations. In this role, the Clinical Support Manager will build, manage, and develop a team of Clinical Support Specialists who provide remote technical assistance to study participants and clinical sites using our investigational medical devices. Responsibilities include hiring, training, and coaching Specialists; setting workflows, coverage, and quality standards for participant and site support; serving as the escalation point for complex device and participant issues; and partnering cross-functionally to continuously improve the support experience. This is a leadership opportunity to shape how Cognito supports participants and sites as Spectris AD advances toward regulatory review and potential commercialization. The ideal candidate is an experienced people leader who thrives in a dynamic, fast-paced environment and brings a patient-focused, collaborative, and solutions-oriented approach to their work. They build high-performing teams through clear expectations, regular coaching, and a culture of accountability and empathy. They are highly organized and data-driven, comfortable working with technology, and skilled at turning recurring issues into better processes, training, and documentation. They demonstrate sound judgment when handling escalations, communicate clearly with participants, clinical sites, and leadership, and collaborate effectively with cross-functional teams, including clinical operations, engineering, quality, and medical device professionals. 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, manage, and develop a team of Clinical Support Specialists, including hiring, onboarding, goal setting, ongoing coaching, and performance reviews. · Plan team staffing, schedules, and coverage across assigned clinical study(ies) to ensure timely and consistent support for participants and clinical sites. · Oversee participant device training, ensuring Specialists are trained and qualified to train participants on the sensory stimulation system and that task delegation is appropriately documented. · Serve as the escalation point for complex device-related, participant, and site issues, partnering with engineering, the study team, and the Principal Investigator to drive swift and effective resolution. · Ensure safety events, device deficiencies, and protocol deviations identified by the team are promptly escalated and reported in accordance with study procedures. · Oversee adherence monitoring via GSConnect, review engagement trends across participants and sites, and ensure timely notification of trial site contacts in the event of a lack of adherence. · Develop, maintain, and continuously improve support workflows, SOPs, work instructions, and training materials for the Clinical Support team. · Oversee and maintain support ticketing software used to track support requests. · Define and track team performance metrics (e.g., response and resolution times, training completion, adherence trends, participant satisfaction) and report results and trends to Clinical Operations leadership. · Conduct regular quality reviews of participant contact documentation to ensure records are complete, accurate, and inspection-ready, and that study systems are kept up to date. · Ensure the team maintains study blinding and participant confidentiality, and that any instances of unblinding are reported and followed up according to recommended processes. · Identify recurring device and usability issues from support interactions and share insights with engineering and R&D teams to inform product improvements. · Oversee prescreening support, subject training scheduling, and visit scheduling activities performed by the team. · Oversee administrative support activities (e.g., equipment tracking, log management, electronic filing, electronic Trial Master File (eTMF) internal audits) and support audit and inspection readiness. · Provide hands-on participant and site support as needed, including during periods of high volume or to cover team absences. · Contribute to planning for scaling support operations as Cognito prepares for potential commercialization. · Perform additional duties for assigned clinical study(ies) as delegated by the Sr. Director, Clinical Operations. Qualifications · Bachelor’s degree in life sciences, health sciences, engineering, or a related field, or equivalent experience · Minimum of 6 years of experience in clinical research, patient support, technical support, or customer service, including at least 2 years in a people management or team lead role · Experience supporting participants or end users of medical devices, digital health technologies, or other technical products; clinical trial experience strongly preferred · Demonstrated ability to hire, coach, and develop high-performing teams and to manage team schedules, workload, and performance · Experience building and improving support processes, SOPs, and/or training programs, and using metrics to drive improvement · Must be qualified by education, training, and experience to perform and oversee any tasks delegated to him/her/them by the study team · Strategic thinking, sound judgment, and strong problem-solving aptitude · Excellent verbal and written communication skills, with the ability to communicate effectively with participants, clinical sites, and leadership · Familiarity with support ticketing or CRM tools and/or clinical trial systems (e.g., EDC, CTMS, eTMF) preferred · Ability to travel up to 25% Preferred Qualifications: · Recent (within the last three years) training in good clinical practice · Strong working knowledge of ICH-GCP, US CFR (including 21 CFR Parts 11 and 812), and HIPAA regulations · Experience with adverse event and device deficiency reporting 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 recruitingteam@cognitotx.com. 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.