Clinical Trials Project Manager

Summary

Yale University is a research and educational institution. The Clinical Trials Project Manager provides sponsor-level project management and operational leadership for investigator-initiated and oncology clinical trials, coordinating studies across their full lifecycle. The role oversees project plans, cross-functional deliverables, regulatory compliance, risk mitigation, stakeholder communication, site activation, and budgets.

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

Skills

• 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 (GCP) 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
• Proven experience with oncology research
• Certification as a Clinical Research Associate or Clinical Research Professional (ACRP, SOCRA, or equivalent) preferred

Qualifications

Must Haves

• 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 (GCP) 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

Nice to Haves

• Proven experience with oncology research
• Certification as a Clinical Research Associate or Clinical Research Professional (ACRP, SOCRA, or equivalent) preferred

Benefits

• This is a remote position. Job seekers who live within one of Yale’s approved work states are encouraged to apply.