Job Title: Clinical Trials Project Manager
University Job Title: YCCI Project Manager, Oncology
Responsibilities:
- Direct and lead 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.
- Identify, track, and analyze barriers in current clinical trials processes, and recommend project management process improvements to the AD, Clinical Operations and broader CTO Leadership Team.
- Organize and project manage multiple projects and clinical trials, across internal and external teams from start-up to close-out. Act 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.
- Collaborate 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.
- Work 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.
- Design, develop, and execute 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). Ensure potential risks and issues related to administrative management of clinical studies are identified, managed, and/or escalated as appropriate to AD Clinical Operations.
- Effectively manage project budgets to ensure financial targets are met through regular reviews of costs and project resources.
- Coordinate site qualification and site initiation visits. May present information to sponsors and other key stakeholders.
- Evaluate and score protocols in a staffing acuity tool as part of study activation.
- Determine and provide final approval for local study activation by ensuring all appropriate regulatory and institutional approvals are met, appropriately documented and communicated.
- Perform other duties as assigned.
Required Skills and Abilities:
- Strong knowledge of Good Clinical Practice guidelines. Demonstrated experience interpreting federal, state, institutional policies and regulations. Ability to interpret complex clinical trial protocols and federal, state, local guidelines, and contracts.
- Able to hold self and others accountable to achieve timebound results. Flexible approach and ability to adapt to shifting demands of evolving priorities. Focused 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 and integrity in a professional manner, sensitivity to confidentiality, and a commitment to protecting research participants. Ability to communicate clearly and effectively, both verbally and in writing.
- Able to manage time effectively and work independently and within a team to meet objectives. Strong attention to detail and demonstrated skill working with minimal supervision. Ability to focus on detailed information and perform tasks requiring precision.
- Excellent computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
Preferred Education:
Previous experience with oncology research.
Education, Experience and Skills:
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.
Work Week:
Standard (M-F equal number of hours per day)
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