Clinical Research Project Manager - Project Hire

About Us Senseye is a NeuroTechnology Company in Austin, TX, on the cusp of revolutionizing Mental Health. Over the past six years, we have invested millions of dollars in R&D to build our platform, allowing us to measure cognitive activity via the eye through mobile phones. Through multiple iterations and use cases, we are now focused on building the world's first objective mental health diagnostics on top of our core technology. Our first diagnostic is for PTSD and is entering clinical trials now, followed soon by additional indications for anxiety and depression. As the world struggles with a mental health crisis, we believe an objective diagnostic platform that gives clinicians a safe and accurate approach to identifying and monitoring mental health disease will redefine how mental health services are provided and enable access to treatment for millions of sufferers. This is an excellent opportunity to shape the future of digital medicine and address unmet medical needs that affect billions of people worldwide. What we are looking for This is a fixed‑term project role through the completion of our Phase III trial. Strong performers may be considered for permanent positions as the team grows. This role will be responsible for managing Senseye as a virtual site in the Phase III study. Experience in site management, particularly in a virtual or decentralized model, is required. The anticipated duration of the project is expected to be between 6‑12 months. The Clinical Research Project Manager is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI and internal teams to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study. Responsibilities Oversee all aspects of Senseye's virtual site for the Phase III trial Schedule, screen and perform study visits Implement and manage clinical trials from start to finish, including providing input to protocol development, patient enrollment, and data analysis Serve as the primary liaison between the company, clinical investigators, and regulatory agencies to ensure compliance with all federal, state, and institutional regulations Develop and maintain trial timelines, budgets, and resources, adjusting as necessary to meet project milestones Train and supervise junior clinical research staff, ensuring adherence to study protocols and regulatory requirements Prepare and submit regulatory documents, such as IRB applications, informed consents, and progress reports, ensuring timely approval and compliance Collaborate with cross‑functional teams, including R&D, Quality Assurance, and Product, to ensure seamless integration of clinical research findings into product development and marketing strategies Analyze and interpret clinical data, preparing detailed reports and presentations for internal and external stakeholders Stay abreast of industry trends, regulatory updates, and emerging technologies in software as a medical device (SaMD) research, applying best practices to enhance trial efficiency and effectiveness Qualifications Bachelor's degree in a life sciences or related field Minimum of 5 years of experience in clinical research coordination, preferably in the medical device industry, with a proven track record of successful trial management Experience managing a clinical research site(s), particularly in a virtual or decentralized trial model Comprehensive understanding of FDA regulations, ICH GCP guidelines, and other applicable regulatory requirements Exceptional organizational, leadership, and problem‑solving skills Strong communication and interpersonal skills, with the ability to work effectively in a team environment and interact with all levels of management, clinical sites, and vendors Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Microsoft Office Suite Excellent verbal and written communication skills in English Pro‑active, committed and motivated attitude Ability to work well in a team environment but also independently without significant oversight Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines Analytical skills sufficient to solve problems Ability to work flexible hours to accommodate research deadlines Ability to concentrate and focus in a work environment with distracting stimuli and competing deadlines Ability to be flexible in handling work delegated by more than one individual or in the course of delegating work Skill in managing diverse, complex tasks and information transfer among multiple constituents Sufficient math ability and knowledge of clinical trials budgeting processes to manage the preparation of clinical trial budgets Preferred Qualifications Master's degree or higher in a life sciences or related field preferred Experience with clinical trials in the mental health space strongly desired Experience with SaMD trials strongly desired Salary range: $123,000 - $149,000 Benefits The anticipated duration of the position is less than one year, so the role is not initially eligible for company-sponsored benefits. If the position extends beyond one year, benefit eligibility will be determined in accordance with the Company's benefit plans and eligibility requirements in effect at that time This position follows a hybrid work schedule. Employees are expected to work in the office on a regular basis and may work remotely as approved by their manager and based on business needs Commuter benefits for parking, public transit, car shares, etc. Fully stocked kitchen #J-18808-Ljbffr Senseye, Inc.