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Yale logo

Clinical Trials Project Manager

Yale
Posted 7 hours ago
🇺🇸United States🏠Remote💰$68K–$120.5K📁Healthcare/Clinical
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Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Overview The Clinical Trials Project Manager provides sponsor level project management and operational leadership for investigator-initiated clinical trials (IITs) and clinical trials conducted through the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) for which the institution and/or investigator has sponsor, coordinating center, or National Principal Investigator responsibilities. Reporting directly to the Director of Operations, this position serves as the central sponsor level project management resource across the full lifecycle assigned oncology trials. The Project Manager partners closely with Principal Investigators, Clinical Research Managers, regulatory and clinical operations teams, contracting and finance, pre-award, laboratories, external vendors and funders, and participating institutions to move studies from concept and feasibility through activation, conduct, closeout, and required reporting. The role is responsible for establishing project plans, timelines, milestones, and accountability structures; coordinating cross-functional deliverables; identifying and mitigating operational and administrative risks; and ensuring that sponsor and institutional responsibilities are completed in accordance with applicable regulations, Good Clinical Practice, institutional policies, study-specific requirements, and contractual obligations. This is a remote position. Job seekers who live within one of Yale’s approved work states are encouraged to apply. Required Skills and Abilities 1. Ability to manage time effectively and work independently and within a team to meet objectives, with strong attention to detail. 2. Strong knowledge of Good Clinical Practice (GCP) guidelines and the ability to interpret federal, state, local, and sponsor policies and regulations. 3. Ability to hold self and others accountable to achieve timebound results, with a flexible approach to adapting to shifting demands. 4. Demonstrated ability to provide proactive, customer service-focused communication and advice, with a commitment to protecting research participants. 5. Strong computer skills, including competency with Microsoft Office programs (Word, Excel, PowerPoint). Preferred Skills and Abilities 1. Proven experience with oncology research. 2. Certification as a Clinical Research Associate or Clinical Research Professional (ACRP, SOCRA, or equivalent) preferred. Principal Responsibilities 1. Directs and leads the development, implementation, and management of clinical trials processes in compliance with SOPs and relevant regulations; liaise with Clinical Research Manager (CRM) to ensure successful clinical trials conduct. 2. Identifies, tracks and analyzes barriers in current clinical trials processes, and recommends project management process improvements to the AD, Clinical Operations and broader CTO Leadership Team. 3. Organizes and project manages multiple projects and clinical trials, across internal and external teams from start-up to close-out. Acts as an expert resource and the primary liaison between the site and internal/external stakeholders to ensure timely study launch, administrative study maintenance, and closeout in accordance with local, state, and federal regulations, as well as contractual obligations. 4. Collaborates with CRM and Principal Investigator (PI) on assessment and implementation of oncology trials for the research team. Including identifying study activation timelines and metrics, resolving potential discrepancies and/or barriers to enrollment prior to study activation, assessing trial acuity for resourcing purposes, and project managing deliverables across teams to meet deadlines. 5. Works closely with leadership, internal constituents, ancillary committees, External Sponsors, and Contract Research Organizations (CROs) to resolve site-level barriers to activation and improve protocol activation timelines. 6. Designs, develops, and executes communication systems to ensure effective and transparent exchange of information between project stakeholders, including the sponsor, regulatory team, clinical research operations team, pre-award team, contracting team, and Clinical Research Support Laboratory (CRSL). Ensures potential risks and issues related to administrative management of clinical studies are identified, managed, and/or escalated as appropriate to AD Clinical Operations 7. Effectively manages project budgets to ensure financial targets are met through regular reviews of costs and project resources. 8. Coordinates site qualification and site initiation visits. May present information to sponsors and other key stakeholders. 9. Responsible for evaluating and scoring protocols in a staffing acuity tool as part of study activation. 10. Works closely with leadership, internal constituents, ancillary committees, Industry Sponsors, and Contract Research Organizations (CROs) to resolve site-level barriers to activation and improve protocol activation timelines. 11. Determines and provides final approval for local study activation by ensuring all appropriate regulatory and institutional approvals are met, appropriately documented and communicated. 12. Performs other duties as assigned. Required Education and Experience A Bachelor’s degree in a relevant academic/scientific field and a minimum of four years of experience in clinical research or an equivalent combination of education or experience. Job Posting Date 09/11/2026 Job Category Professional Bargaining Unit NON Compensation Grade Administration & Operations Compensation Grade Profile Manager; Program Leader (24) Salary Range $68,000.00 - $120,500.00 Time Type Full time Duration Type Staff Work Model Remote 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.

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