Clinical Trials Manager

Overview Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven‑based community or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! The Clinical Trials Manager is responsible for the coordination, implementation, and evaluation of all administrative aspects of clinical trial conduct, including feasibility, clinical research support, study prioritization, protocol review, study initiation, study maintenance, activation, and closeout activities. Directs and leads the development, implementation, and management of clinical trials processes in compliance with SOPs and relevant regulations. Identifies, tracks and analyzes barriers in current clinical trial processes, and recommends project management process improvements to the Leadership Team. Responsible for the management and administration of all aspects of the Heart and Vascular Center Clinical Trials program, including planning, organizing, staffing, leading, and controlling program activities. This position plans the delivery of the overall program and its activities in accordance with the mission and goals of the organization. This role will collaborate with Internal Medicine’s Post‑Award team on matters related to research compliance and financial management, ensuring adherence to sponsor requirements and institutional policies. Required Skills and Abilities Able to manage time effectively and work independently and within a team to meet objectives, with strong attention to detail and demonstrated skill working with minimal supervision. Able to hold self and others accountable to achieve time‑bound results; flexible approach and ability to adapt to shifting demands, focusing on continuous process improvement and efficiency to optimize workflow. Demonstrated ability to provide proactive, flexible, and customer‑service‑focused communication and advice; work effectively with others and demonstrate ethics, integrity, sensitivity to confidentiality, and a commitment to protecting research participants. Knowledge of Good Clinical Practice guidelines and experience interpreting federal, state, local, and sponsor policies and regulations. Strong computer skills, including competency in Microsoft Office programs. Preferred Skills and Abilities Certification as a Clinical Research Associate or Clinical Research Professional (ACRP, SOCRA, or equivalent) preferred. Principal Responsibilities Oversees the advancement and growth of the program, giving direction and leadership to support the philosophy, mission, strategy, and annual goals and objectives, and assumes primary accountability for disseminating and publishing all program information to create public awareness and support. Plays a key role in strategic planning; works closely with leadership, internal and external colleagues, and community residents to develop new initiatives and implement long‑term goals and objectives to achieve successful outcomes. Develops an annual budget and operating plan, ensures the program operates within the approved budget, monitors and approves all budgeted program expenditures, and manages all program and project funds according to established accounting policies and procedures. Builds and maintains a program evaluation framework to assess strengths and identify improvement areas; monitors program activities regularly and conducts an annual evaluation; identifies and evaluates risks associated with program activities and takes appropriate action to control them; reports findings to stakeholders and recommends changes to enhance the program. Ensures program activities operate within the organization’s policies and procedures and comply with all relevant legislation and regulatory requirements. Identifies, solicits, and cultivates community partnerships and collaborations to support program development and growth; develops metrics to measure program success and is responsible for grant‑success measurement and related evaluation. Identifies and evaluates potential future funding sources, and contributes to the submission of grants and contracts supporting the program, including annual submission and writing of all content areas and budgetary sections of grant applications. Develops the administrative infrastructure, manages human‑resource and administrative functions of the program—including staffing, hiring, supervision, performance development, counseling and discipline—and oversees information systems, facilities, and space needs. Investigates, identifies, implements, and oversees systems to gather, track, and report information to support program initiatives; tracks all program activities and regularly informs leadership of progress, recommending structural or programmatic adjustments when needed. Initiates, designs, and manages program communications, identifying outreach potential and promoting philanthropic and collaborative support; assists in managing content on the program’s website and monitors all editorial changes and additions. Performs other duties as assigned. Required Education and Experience Bachelor’s degree in a related field, and six years of related experience or an equivalent combination of education and experience. 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. EEO Statement 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). Additional Information Yale University is a tobacco‑free campus. #J-18808-Ljbffr