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Austin, Texas, United States · Hybrid
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Skills: Participant Recruitment, Clinical Trial Coordination, Good Clinical Practices, HIPAA Compliance, Data Collection
Austin, Texas, United States · Hybrid
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Manage Senseye as a virtual site for a Phase III clinical trial, overseeing participant recruitment, data collection, and regulatory compliance. Coordinate with the Principal Investigator and cross-functional teams to ensure the seamless integration of research findings into product development.
Requires a Bachelor's degree in life sciences and at least 5 years of clinical research experience, specifically with virtual or decentralized trial models. Must possess a comprehensive understanding of FDA and ICH GCP guidelines and proficiency in CTMS and EDC systems.
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, it is not hyperbolic to suggest that an objective diagnostic platform that gives clinicians a safe and objective, accurate approach to identifying and monitoring mental health disease, will redefine how mental health services are provided and will enable access to treatment for millions of sufferers. The Senseye platform could be the technology that drives this change. 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 tirial. 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 Principal Investigator 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.
The Clinical Research Project Manager will coordinate all research-related activities, including the initial set-up of the study, study participant recruitment and retention, delivery of the intervention, data collection, entry, and quality control activities, protocol compliance and patient safety. He/She will also work on monitoring data quality assurance and quality control and study conduct. He/She will work independently in designing, coordinating, and implementing all assignments. The Clinical Research Project Manager is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files. The Clinical Research Project Manager trains other staff in conducting study visits per the study protocol(s).
To succeed in this role, you should have the following skills and experience
Preferred Qualifications
The salary range for this position is $123,000 - $149,000
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Did you know that often women apply for open jobs only if they think they meet 100 percent of the criteria listed? Men will apply to that same posting if they feel they meet 60 percent of the requirements.
We know that not everyone comes from the same background, has had the same experiences, or education, and we wouldn’t want it any other way. Don’t worry about checking every single box, instead we want you to bring your own unique outlook to the team, whatever that might be!
Senseye is building the breakthrough diagnostic platform for mental health, starting with PTSD.
Senseye is building a mental health visibility platform. We will help clinicians personalize care with fast, accurate tools for establishing a clear baseline and tracking outcomes over time.
Offices: 801 Congress Ave Suite 200, Austin, Texas 78701, US
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