Clinical Research Project Manager - Project Hire

About the role

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.

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

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
• Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines
• 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

Skills

• Bachelor's degree in a life sciences or related field
• 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

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