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Yale University

Research university in New Haven, CT

Clinical Trials Project Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeConnecticut, USA$68k - $120.5k

About the Job

Requirements

  • 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, and 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.

Responsibilities

  • Directs and leads the development, implementation, and management of clinical trials processes in compliance with standard operating procedures and relevant regulations; liaises with the Clinical Research Manager to ensure successful clinical trials conduct.
  • Identifies, tracks, and analyzes barriers in current clinical trials processes, and recommends project management process improvements to the Associate Director of Clinical Operations and broader Clinical Trials Office 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 and 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 the Clinical Research Manager and Principal Investigator on assessment and implementation of oncology trials for the research team, including identifying study activation timelines and metrics, resolving potential discrepancies or barriers to enrollment before 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 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. Ensures potential risks and issues related to administrative management of clinical studies are identified, managed, or escalated as appropriate to the Associate Director of 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 and may present information to sponsors and other key stakeholders.
  • Evaluates and scores 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 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.

Desired Qualifications

  • Proven experience with oncology research.
  • Certification as a Clinical Research Associate or Clinical Research Professional (Association of Clinical Research Professionals, Society of Clinical Research Associates, or equivalent) is preferred.

About the Company

Yale University

Research university in New Haven, CT

Yale University is a private research university in New Haven, Connecticut. It provides undergraduate, graduate, and professional education alongside research, scholarship, and public engagement.

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