Yale University · 4 weeks ago
Clinical Trials Project Manager
United States
Full-time
Remote
Mid, Senior Level
$68K/yr - $120K/yr
4+ years expYale University is committed to contributing to a better tomorrow and is seeking a Clinical Trials Project Manager to join their team. This role involves coordinating and overseeing the administrative aspects of clinical trials at the Yale Cancer Center, ensuring compliance with regulations, and facilitating communication among stakeholders to optimize workflows and patient care.
AssociationBusiness DevelopmentEducationMedicalSocial Entrepreneurship
Responsibilities
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
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
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
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
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
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
Effectively manages project budgets to ensure financial targets are met through regular reviews of costs and project resources
Coordinates site qualification and site initiation visits. May present information to sponsors and other key stakeholders
Responsible for evaluating and scoring protocols in a staffing acuity tool as part of study activation
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
Determines and provides final approval for local study activation by ensuring all appropriate regulatory and institutional approvals are met, appropriately documented and communicated
Performs other duties as assigned
Qualification
Required
Ability to manage time effectively and work independently and within a team to meet objectives, with strong attention to detail
Strong knowledge of Good Clinical Practice guidelines and the ability to interpret federal, state, local, and sponsor policies and regulations
Ability to hold self and others accountable to achieve timebound results, with a flexible approach to adapting to shifting demands
Demonstrated ability to provide proactive, customer service-focused communication and advice, with a commitment to protecting research participants
Strong computer skills, including competency with Microsoft Office programs (Word, Excel, PowerPoint)
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
Preferred
Proven experience with oncology research
Certification as a Clinical Research Associate or Clinical Research Professional (ACRP, SOCRA, or equivalent) preferred
Company
Yale University
Yale University is a research and education institution that prioritizes its students.
10001+ employees
H1B Sponsorship
Yale University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (355)
2024 (449)
2023 (214)
2022 (208)
2021 (190)
2020 (155)
Funding
Current Stage
Late StageTotal Funding
$42.86MKey Investors
Bezos Earth FundAlfred P. Sloan FoundationHyundai Hope On Wheels
2025-10-23Grant
2025-05-21Grant· $0.05M
2023-01-01Grant· $1.27M
Leadership Team
Geoffrey Chatas
Senior Vice President for Operations
Jack Callahan
Senior Vice President for Operations
Recent News
2025-12-10
Company data provided by crunchbase