Clinical Research Project Manager - Project Hire

Senseye•Austin, TX

3d•Hybrid

About The Position

Senseye is a NeuroTechnology Company in Austin, TX, focused on revolutionizing Mental Health through its platform that measures cognitive activity via the eye using mobile phones. The company is developing objective mental health diagnostics, with the first for PTSD entering clinical trials, followed by Anxiety and Depression. This role is a fixed-term project position through the completion of a Phase III trial, with potential for permanent employment for strong performers. The Clinical Research Project Manager will manage Senseye as a virtual site in the Phase III study, supporting the Principal Investigator (PI) in coordinating daily clinical trial activities. This includes study setup, participant recruitment and retention, intervention delivery, data collection and quality control, protocol compliance, and patient safety. The role also involves monitoring data quality assurance, quality control, and study conduct, working independently to design, coordinate, and implement assignments. Responsibilities include managing all data and source documentation, adverse event reporting, maintaining regulatory files, and training other staff on study visit procedures.

Requirements

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.

Nice To Haves

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

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.