"YCCI Project Manager, Oncology"

Location

New Haven, Connecticut

Categories

Staff/Administrative

Salary Range

$68,000.00 - $120,500.00

Overview

As a Project Manager specializing in oncology clinical trials, this position is essential to the successful initiation, implementation, regulatory oversight, and close-out of investigator-initiated projects in cancer research. Specifically, the Project Manager will support the sponsor level responsibilities for single and multi-center clinical trials. Serving as an oncology research subject matter expert, the Project Manager will streamline communication and oncology-specific operations between Yale Cancer Center faculty investigators, leadership, and participating site staff and the Yale Center for Clinical Investigation Protocol Design, Development, and Feasibility team. This role is critical to ensuring compliance with Federal regulations, maintaining integrity of study protocols involving human subjects, and facilitating cohesive communication across cross-functional departments. The role will have independent ownership of assigned projects, and responsibility for oversight of timelines and deliverables. This role will also serve to consult with faculty on new projects, support budget development, protocol development, review of contracts and/or grant management (when applicable), and supervision of regulatory submissions during project start up. Other duties as assigned.

The Project Manager:

• Oversees and leads the execution and implementation of detailed project plans in concert with stakeholders.
• Manages a portfolio of research projects and ensures that the design, testing, training, documentation, and prioritization objectives are met.
• Collaborates with Yale Cancer Center faculty and staff to identify and address opportunities related to effective administrative management of clinical studies within the oncology patient population.
• Refines and re-sequences during the implementation and execution phases of assigned projects, as needed.
• Works closely with business analysts, technical professionals, end users and project stake holders during the requirements, solutions design and implementation phases to develop detailed project plans and timelines for deliverables.
• Directs risk assessments, communication planning, development of performance metrics, and project entry criteria.
• Creates detailed project plans including timelines, budgets, and resource allocation to ensure successful project completion.
• Manages client expectations and provides issue/risk identification and escalation pathways.
• Complies with standard policies and procedures.
• May perform other duties as assigned.

Required Skills and Abilities

• 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.
• 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 matter, sensitivity to confidentiality, and a commitment to protecting research participants. Ability to communicate clearly and effectively, both in verbally and in writing.
• Strong knowledge of Good Clinical Practice (GCP) guidelines. Demonstrated experience interpreting federal, state, University policies and regulations. Demonstrated ability with interpreting complex clinical trial protocols and federal, state, local guidelines, and contracts.
• Excellent computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.)

Preferred Skills and Abilities

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

Principal Responsibilities

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.

Required Education and Experience

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.