YCCI IND/IDE Clinical Trials Project Manager

Yale University is seeking an IND/IDE Clinical Trials Project Manager to join their clinical research team. The role involves overseeing clinical trials, providing regulatory expertise, and ensuring compliance with FDA guidelines while managing project plans and stakeholder communications.

Responsibilities:

• Oversees the execution and implementation of detailed project plans in concert with stakeholders
• Manages several routine projects simultaneously and ensures that the design, testing, training, documentation and prioritization objectives are met
• Assists in refining and re-sequencing during the implementation and execution phases of assigned projects, as needed
• Works closely with business analysts, technical professionals, end users and project stake holders during the requirements, solutions design and implementation phases to develop detailed project plans for implementation
• Works on risk assessment, communication planning, development of performance metrics, and project entry criteria
• Creates detailed project plans including timelines, budgets, and resource allocation to ensure successful project completion
• Manages client expectations and provides issue/risk identification and escalation pathways
• May supervise the implementation team of cross-functional project and technical resources
• Designs, develops, and executes communication systems to ensure effective exchange of information between project stakeholders, senior management, and staff
• Resolves complex project issues that involve representatives from multiple organizations
• Complies with standard policies and procedures
• May supervise and train junior project managers
• May perform other duties as assigned

Requirements:

• Previous experience working with FDA and/or EMA regulated clinical trials, and an understanding of regulatory submission, regulatory communication, on-going management, and close-out requirements
• Knowledge of design and methods used in translational and clinical research
• Strong knowledge of federal and state regulations protecting human subjects involved in research, and demonstrated ability interpreting federal, state, University, and sponsor policies and regulations
• General technical knowledge of FDA and EMA clinical trial regulations and regulations for use of investigational new drugs and devices
• Professionalism, maturity, good judgment, the ability to work with confidential material, excellent interpersonal, organizational, communication and project management skills are required
• The ability to work remotely; including an adequate workspace with internet access
• Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience
• A Masters, PhD, PharmD or other advanced degree in a physical or natural science
• Work experience in medical/public health research, clinical trial coordination, medical writing, or IRB review