"Clinical Trials Project Manager"

Overview

The Clinical Trials Project Manager collaborates with the Clinical Trials Office (CTO) Oncology Disease Group to coordinate, implement, and evaluate all administrative aspects of clinical trial conduct at the Yale Cancer Center. Responsibilities include feasibility assessment, protocol review, study initiation, maintenance, activation, and closeout activities. The role involves facilitating the extension of complex clinical trials to network locations, ensuring compliance with federal regulations, and maintaining the integrity of study protocols involving human subjects. The Project Manager serves as a subject matter expert in oncology research, streamlines communication and operations between faculty investigators, leadership, and participating sites, and supports budget development, protocol development, and regulatory submissions. This role requires independent project oversight and a commitment to optimizing workflows and ensuring high-quality patient-centered care and research.

Required Skills and Abilities

1. Ability to manage time effectively and work independently and within a team to meet objectives, with strong attention to detail.
2. Strong knowledge of Good Clinical Practice guidelines and the ability to interpret federal, state, local, and sponsor policies and regulations.
3. Ability to hold self and others accountable to achieve timebound results, with a flexible approach to adapting to shifting demands.
4. Demonstrated ability to provide proactive, customer service-focused communication and advice, with a commitment to protecting research participants.
5. Strong computer skills, including competency with Microsoft Office programs (Word, Excel, PowerPoint).

Preferred Skills and Abilities

1. Proven experience with oncology research.
2. 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.

Salary Range

$68,000.00 - $120,500.00

Location

221 Whitney Ave, New Haven, Connecticut

Work Model

Remote

Time Type

Full time