Clinical Trial Manager

Remote       ·       Full time

Full Job Description

Position Title: Clinical Trial Manager
Location: Cambridge, MA

Company Description

Cognito is a venture backed (Morningside Ventures) clinical stage company advancing the field of neuromodulation to create novel therapeutics that improve the lives of patients living with neurodegenerative diseases. Cognito is built on the scientific findings from MIT into therapeutic approaches for Alzheimer’s disease and other neurodegenerative conditions. We are a fast moving, highly motivated team of people with the ambitious goal of helping the millions of Alzheimer’s disease patients and caregivers around the world by harnessing the brain’s innate restorative systems to create a new era of medical treatments. With our patented gamma stimulation technology, we are committed to developing non-invasive device-based therapies.

Summary of Role

The Clinical Research Program Manager and 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 and interfacing with company Program Management team to coordinate complex operations.

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
• 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

• Science or engineering background preferred (M.S. or B.S.) 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), including extensive participant contact
• Understanding of medical and statistical scientific methodology
• In-depth understanding of the legal and regulatory environment of the medical device/ pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics
• Versed in the collection of physiological and psychological data and associated data streams
• Experience with and understanding of the challenges and controls required for appropriate psychometric evaluations
• Good communication skills; team oriented

Desired Qualifications

• Experience with populations with neurogenerative diseases
• Experience managing entry-level clinical team members
• A background in brain stimulation technology is a plus

Job Type: Full-time
Schedule: Monday to Friday
Work Location: Remote

Please click here to apply.