Clinical Trials Project Manager

Title: Clinical Trials Project Manager

Location: Off Campus within  New Haven- Connecticut

Work Type: Remote, Full Time

Job ID: 133678WD

Job Description:

Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale!

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.

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

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 (GCP) 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.

Compensation Grade

Administration & Operations

Compensation Grade Profile

Manager; Program Leader (24)

Salary Range

$68,000.00 - $120,500.00

Duration Type

Staff

Health Requirements

Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.

Posting Disclaimer

Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and current internal and external market conditions.
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties throughtheir hiring department.
The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

Note

Yale University is a tobacco-free campus.