YCCI IND​/IDE Clinical Trials Project Manager

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As an integral member of the IND/IDE centralized clinical trials project management team for clinical research, the position ensures an environment that promotes quality research management and facilitates interdisciplinary research activities. The IND/IDE Clinical Trials Project Manager is responsible for the support of clinical trials under an IND or IDE held by Yale faculty. With guidance from the Associate Director of IND/IDE Management, provides technical and regulatory expertise to research faculty and staff, YCCI teams and any required subcontractors in accordance with the current Food and Drug Administration (FDA) Rules/ Guidance and Yale policy.

The Project Manager will also provide clear and valid IND/IDE guidance to Yale faculty and staff throughout the research and development process and ensure clear and effective IND/IDE submissions and presentations for regulatory agencies, senior management and external parties. The Project Manager represents Yale in communications and meetings with the FDA, European regulatory agencies and other regulatory bodies. Along with the IND/IDE Associate Director, serves as liaison to the NIH/NCATS Program leadership and officers and other key CTSA-consortium collaborators with respect to the IND/IDE portfolio.

The Project Manager further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinate initiatives which identify, prevent, and appropriately mitigate multisite trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university’s broader compliance strategy and framework.

The position coordinates effectively with other units/departments within the university such as biostats (YCAS), EHR research team (JDAT), Human Subjects Protections (HRPP), industry contracting team, and finance; clinical trials sponsors and vendors; and with research teams at other academic centers. Familiar with a variety of the field's concepts, practices, and procedures and relies on experience and judgment to plan and accomplish goals.

This is a remote position. Job seekers who live within one of Yale’s approved work states are encouraged to apply.

Under direction of the Associate Director/designee, guides 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. Designs, develops, and executes communication systems to ensure effective exchange of information between project stakeholders, senior management, and staff. Complies with standard policies and procedures.

May perform other duties as assigned.

• 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…