Job Responsibilities:

As a Clinical Trial Manager, you will manage the clinical trial program in short-term planning, long-term planning, operationalization, and deployment of the clinical trial infrastructure to test a highly novel, large-scale neural interface for direct communication with the brain. Manage a team of clinical research associates, clinical research coordinators, and technical writers to create clinical trial operational plans, practices, and documentation for all clinical trials. Manage the implementation, on-time execution, and conduct of clinical studies. Manage the development of study plans, timelines, and vendor selection to ensure quality and compliance. Identify potential risks that may impact clinical studies, e.g., study data, ethical conduct, and adherence to ICH guidelines, and provide risk mitigation solutions. Appropriately manage the various stages of study activities, e.g., start-up, treatment, maintenance, and close-out to ensure the study is conducted on time and within budget. Understand the data requirements of clinical studies to ensure the quality and integrity of data during collection, review, cleaning, and monitoring. Manage creating and updating of clinical trial standard operating procedures. Manage clinical work activities of direct reports. Design and create clinical trial protocols, consent documentation, and participant-facing materials as they relate to clinical trial implementation. Establish and manage relationships with external partners, such as institutional review boards, clinical trial sites, investigators, medical consulting specialists, and all other entities required to successfully run a clinical trial. Interface with, and manage contributions from, contract research organizations with trial operations. Contribute to regulatory interactions as they relate to clinical trial implementation and operationalization. Will supervise 1 Regulatory and Technical Writer.

Key qualifications:

• Working with FDA breakthrough status designated technology
• Mitigating risk clinical trials from psychiatric and cognitive perspectives
• Working in neurosurgery and neuromodulation research and clinical trials on the study or sponsor side
• Operating room procedures: attire, sterilization, surgical equipment, and surgical procedures and workflows
• Medical device clinical trial design, implementation, and life cycle
• Using project management software: Basecamp, designing and developing case report forms using electronic platforms
• Working in vivariums, medical facilities (hospitals, clinics, surgery centers), and operating rooms
• Managing stakeholders and teams to set and achieve milestones

Preferred qualifications:

• Master's degree or foreign equivalent in Neuroscience, Biology, or related field
• Two (2) years of experience as a Clinical Trials Project Manager, Clinical Research Coordinator, or related occupation.