YCCI IND/IDE Clinical Trials Project Manager

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Overview
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.

Essential Duties: 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.

Required Skills and Abilities
1. 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.
2. Knowledge of design and methods used in translational and clinical research.
3. 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.
4. General technical knowledge of FDA and EMA clinical trial regulations and regulations for use of investigational new drugs and devices. 
5. 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.

Preferred Education, Experience and Skills

1. A Masters, PhD, PharmD or other advanced degree in a physical or natural science.

2. Work experience in medical/public health research, clinical trial coordination, medical writing, or IRB review.

Principal Responsibilities

Required Education and Experience

Bachelor’s Degree in a related field and five years of related work experience or equivalent combination of education and experience.

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Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

Health Requirements

Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.

Posting Disclaimer

Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and current internal and external market conditions.

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties through  their hiring department.

The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

Note

Yale University is a tobacco-free campus.