Company Description

Cognito Therapeutics, Inc. is a pre-IPO medtech company translating scientific findings from MIT into therapeutic approaches for Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Cognito’s Ph3 Alzheimer’s trial is over 50% enrolled as of January 2024, and expects to start additional clinical studies in Multiple Sclerosis and Parkinson’s Disease in 2024. We are a fast-moving, highly motivated team of people with the ambitious goal of helping millions of patients and caregivers around the world who are burdened with neurodegenerative conditions. With our patented gamma stimulation technology, we are committed to developing non-invasive device-based therapies.

Summary of Role

The Clinical Data Manager participates in research and development activities within the Clinical Operations team at Cognito. This role is responsible for clinical trial data management activities, including database design and edit check development, query generation/processing, query resolution, reconciliation of CRF and electronic data, and database cleaning and lock activities. The Clinical Data Manager will work alongside the third-party data management/biostats vendor to ensure all data management activities are completed appropriately. The Clinical Data Manager will also be responsible for central source document verification of data captured through Optical Mark Read (OMR). In addition, the role will work closely with the in-house biostatistician in support of interim and final analysis reporting.

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:

• Conduct clinical data management activities using Medrio Data Management Systems, or other similar platforms
• Work with external vendors on routine data transfers and data transfer agreements
• Preparation of data sets for regular Data Monitoring Committee meetings; collaboration on development of DMC materials
• Interim Analysis data set preparation and management

• Involved in data preparation for reporting clinical study results for regulatory filings, publications, presentations
• Provide comprehensive data management expertise to internal and external teams
• Serve as the primary point of contact for all data management related deliverables
• Develop work instructions and processes associated with data management activities
• 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 workflow
• Responsible for timely identification of problems or issues that could affect study results or timelines

• Perform and document database and report User Acceptance Testing (UAT), including developing test scripts and test data for UAT
• Review medical coding listings
• Perform SAE reconciliation
• Create written data management plans, edit check specifications, CRF completion guidelines, data transfer specifications, as well as any other required study-specific data management documents
• Prepare training materials and user guides for EDC data collection tools, as needed
• Develop the Data Management Plan (DMP)

Qualifications

Minimum Qualifications

• Science background preferred (M.S. or B.S.) with 3 years of experience of managing clinical trial data in a CRO, pharmaceutical, medical device or biotech company
• Excellent analytical and problem-solving skills
• 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 legal and regulatory environment of the medical device/ pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics
• Experience with a multitude of data management systems (Medrio, Medidata Rave, etc)
• Good communication skills; team oriented

Desired Qualifications

• Experience with populations with neurodegenerative diseases
• Ability to travel to office In Cambridge, MA (10-15%) for company meetings