YCCI IND/IDE Clinical Trials Project Manager

Yale University - New Haven, CT

Full-time - Mid Level

Remote - New Haven, CT

Educational Services

About the position

The YCCI IND/IDE Clinical Trials Project Manager at Yale University plays a crucial role in managing clinical trials under an IND or IDE. This position ensures quality research management and facilitates interdisciplinary research activities, providing technical and regulatory expertise to faculty and staff. The Project Manager is responsible for effective communication with regulatory agencies and ensuring compliance with FDA regulations, while also coordinating with various university departments and external partners.

Responsibilities

• Manage special projects from inception to completion, requiring quantitative analysis and independent research.
• Design and develop communication strategies for special projects, ensuring effective stakeholder engagement.
• Create and author high-level written materials and serve as coordinator for internal and external committees.
• Serve as Secretary for committees, managing correspondence and resolution processes.
• Supervise project coordinators and administrative staff as needed.
• Act as a liaison to other departments for all communications.
• Contribute to the design and maintenance of the department website.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree in a related field and four years of related work experience or an equivalent combination of education and experience.
• Previous experience with FDA and EMA regulated clinical trials, including IND and IDE submissions.
• Knowledge of design and methods used in translational and clinical research.
• Strong knowledge of federal and state regulations protecting human subjects in research.
• General technical knowledge of FDA and EMA clinical trial regulations (GCP).
• Excellent interpersonal, organizational, communication, and project management skills.

Nice-to-haves

• A Master's, PhD, PharmD, or other advanced degree in a physical or natural science.
• Experience in medical/public health research, clinical trial coordination, medical writing, or IRB review.

Benefits

• Health insurance
• Paid holidays
• Flexible scheduling
• Professional development opportunities