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.
Preferred Education: Previous experience with oncology research.
Preferred Education, Experience and Skills: Previous experience with oncology research.
Required Skill/ability 5: Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
Posting Position Title: Clinical Trials Project Manager
Required Skill/ability 3: 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 matter, sensitivity to confidentiality, and a commitment to protecting research participants.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Clinical Trials Project Manager
Required Skill/ability 1: Ability 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.
Required Skill/ability 4: Knowledge of Good Clinical Practice guidelines. Demonstrated ability interpreting federal, state, local and sponsor policies and regulations.
Required Skill/ability 2: Ability to hold self and others accountable in order 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.
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.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.