Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) company translating scientific findings from MIT into therapeutic approaches for Alzheimer’s disease and other neurodegenerative conditions. We received FDA Breakthrough Device Designation based on our Phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Our device is in a pivotal study for first-line treatment of Alzheimer’s, with potential expansion into Mild Cognitive Impairment (MCI) and Parkinson’s Disease. We are a fast-moving, highly motivated team with a bold mission of bringing a novel therapy to the millions of patients in the world suffering from neurodegenerative diseases. With our patented gamma stimulation technology, we are committed to developing a pipeline of non-invasive device-based therapies.

Summary of Role

The Clinical Trial Manager participates in research and development activities within the Clinical Operations team at Cognito. This role is responsible for managing the planning, implementation, and tracking of the clinical monitoring process, administration of clinical research, the science of determining the safety and effectiveness (prevention, treatment, diagnosis and/or symptom relief) of investigational interventions for human use. In addition, the role is responsible for managing the tasks and timelines for the Clinical Operations team as well as taking responsibility for particular aspects of the clinical trial management.
Our culture is very open and innovative, and due to the multidisciplinary nature of building a complex device, you will be collaborating with teams from a variety of fields, including clinical sites, contract research teams, neuroscientists, engineers, and medical device professionals. Successful teammates are committed to the collaboration and new technology and enjoy a small, flexible and innovative team.

Deliverables
You will be responsible for:

• Independently planning and implementing all components of clinical trials in accordance with protocols and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICHs and applicable local regulations
• Documenting processes through development of Work Instructions and study specific plans, then documenting adherence thereto
• Establishing and maintaining relationships with trial sites, monitoring/co-monitoring, managing, and closing clinical study sites
• Reviewing and overseeing CRO activities, review of monitoring reports, and monitoring vendor KPIs
• Collaborating with colleagues at all levels and in all departments of the company to ensure company success, including coordinating activities and timelines between members of the Clinical Operations team and communicating with company Program Management team
• Liaising with CROs and other clinical vendors as directed to ensure deliverables are met and methods of communication are developed to facilitate efficient work flow
• Assisting in the management of study progress reporting (from protocol development and planning to study close-out) to assure adherence to intended timelines, internal communication, and achievement of key milestones and overall study goals
• Managing and maintaining eTMF and auditing CRO eTMF

Minimal Qualifications

• Education: Bachelor's level or higher with 3 years of experience of managing clinical trials within biotech
• Comprehensive understanding of clinical development strategies and trial designs
• Human subjects research background (5 years preferred)
• Understanding of medical and statistical scientific methodology
• Understanding of the regulatory environment of the medical device/ pharmaceutical industry, demonstrated integrity and solid ethics
• In-depth understanding of clinical trial site operations and conduct, ability to clearly communicate with clinical sites and conduct on-site trainings and refresher trainings
• Ability to work effectively independently, as well as part of a team
• Strong problem solving abilities, able to adapt to changing environments and requirements
• Excellent interpersonal and communication skills; team oriented

Desired Qualifications
• Experience with populations with neurodegenerative diseases