Clinical Research Project Manager - Project Hire

Job Description

Job Description

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).

Requirements

• 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.

To succeed in this role, you should have the following skills and experience

• 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 communications skills in English language

• Excellent interpersonal and organizational skills

• A 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 work and solve problems.

• Ability to work flexible hours to accommodate research deadlines.

• Ability to concentrate and focus in a work environment that contains 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

The salary range for this position is $123,000 - $149,000

Benefits

• The anticipated duration of the position is less than one year, this role is not initially eligible for company-sponsored benefits. Should the position extend 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, carshares, etc.

• Fully stocked kitchen

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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!