Clinical Research Billing Compliance Manager

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Overview
The Manager, Clinical Research Billing Compliance, leads and supports the day-to-day operations of clinical trial and research billing compliance activities. This role ensures accurate and compliant billing for research-related services by overseeing the Yale Center for Clinical Investigation (YCCI)  Research Billing Compliance Team, consulting with the Financial Teams with YCCI’s Protocol Activation and Lifecycle Management (PALM) team, advising on development of billing plans, and ongoing monitoring. This position is responsible for collaborating with all relevant departments within Yale, and Yale New Haven Health System (YNHHS) including YCCI-PALM, Yale clinical research study teams, YNHHS revenue cycle and research finance teams, etc.

Position Focus  

Reporting to the Associate Director, Clinical Research Finance and Resource Utilization YCCI within the Yale School of Medicine, this position manages the development, implementation and monitoring of an effective clinical research billing compliance program, coordinating the clinical research billing reviews and monitoring efforts for clinical trials conducted at the Yale Medical School (including the School of Public Health). The position oversees an internal research billing compliance program and team; the implementation of quality control measures to promote safety and compliance and the integration of QA with multiple review committees. A critical component of the role is to identify to the Directors any compliance concerns and recommend solutions to improve the overall operations, the safe and efficient conduct of clinical trials and educational and training opportunities for faculty and staff.  

Principal Responsibilities  

• Leads, manages and advises on the current change management program for improving the clinical research billing compliance program at Yale. This includes working with current staff and vendors to develop, implement, monitor and report on outcomes of the updates and improvements being made to the current program. While the program will be in the change management process at time this position is filled, ongoing quality and change management will be expected for this role moving forward.  

• Leads, manages, and advises on clinical research billing compliance matters as assigned. This includes serving as an expert resource regarding applicable laws, regulations, and standards governing clinical research billing conducted in the United States and other countries; providing advice and ensuring the efficient review, identification, and resolution of issues with a focus on customer service and compliance; and delivering relevant training.   

• Leads, manages, and advises on clinical research billing compliance matters as assigned.  This includes leading, managing, and advising on the following: clinical research billing compliance activities (e.g., Physician and Hospital Billing charge review, clinical research billing audits, Clinical Trial Management System (OnCore) patient billing plan set up and execution, research billing audits, etc.), systemic reviews to evaluate billing compliance to ensure compliance with all federal, state and local laws and regulations governing research billing compliance, responding to patient billing inquiries.

• Leads, manages, and advises on clinical trial billing operational matters and ensures operational efficiency and compliance with laws, regulations, and standards related to the conduct of clinical trial billing compliance. This includes leading, managing, and advising on the following:  departmental and cross-departmental initiatives, projects, and requests for assistance by the University community; delivery of day-to-day service levels, customer experience, and billing compliance; change management within the billing compliance department in accordance with changes to laws and regulation governing the topic; collaborations with other business units; operational effectiveness and strategies to ensure quality and efficiency; operational opportunities, risk management, continuous quality improvement; and verifying that institutional requirements have been satisfied.   

• Leads, manages, and advises on relationships external to the YCCI, YNHHS and University as assigned. This includes: facilitating discussions with research investigators, program directors and high-ranking officials from external institutions or organizations who are interested in pursuing a collaborative research affiliate relationship with Yale University; collaborating with ancillary committees, departments, and organizations external to Yale regarding clinical research billing. 

• Leads, manages, and advises on matters related to YCCI accounts receivable, billing, and financial forecasting and reporting as assigned.  

Required Skills and Abilities
1. Demonstrated expertise and a comprehensive understanding of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research.  
2. Demonstrated ability to manage, organize, and execute complex projects; multi-task, identify, analyze, and resolve problems efficiently and effectively; use independent good judgment and to assess risk; and independently follow-through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.  
3. Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches; and ability to distill and communicate complex information into understandable information.  Proactive, flexible, and customer service focused with the ability to work effectively with others; and demonstration of ethics and integrity in professional matters, sensitivity to confidentiality, and commitment to protecting research participants.  
4. Demonstrated ability to provide guidance regarding clinical research billing compliance requirements and resolve issues. Demonstrated experience operating a successful billing compliance program at similar organization which includes all aspects of a clinical research billing compliance program including but not limited to: Understanding of Center for Medicare/Medicaid Services (CMS) laws, rules and regulations; National and Local Coverage Determinations; Coverage Analysis development and implementation within patient bills; experience with Clinical Trial Management System (CTMS) and Electronic Medical Records (EMR) system.  
5. Demonstrated technology and software application skills; ability to learn new software packages; highly skilled in office productivity software (e.g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.); and knowledge of technology platforms used in research (e.g., Epic, Oncore, CRPC, IRB management, clinical trial management, and related platforms).

Preferred Education and Experience  

1. 7 years of relevant experience in research administration or clinical research billing with 5 years prior experience at a large academic institution, hospital/medical center, academic/independent IRB, or non-profit organization/foundation.

2. At least 2 years managing a clinical research billing compliance team (inclusive of exposure to both pre and post award Clinical Research Billing practices) within a healthcare organization. Research Compliance, Certified Clinical Research Professional or other relevant certification.

3. Experience in a leadership/consultancy role.

4. Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process.

Principal Responsibilities

1. Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department of the University. 2. Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions and assistance as needed. 3. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 4. Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments. 5. Manages the use of facilities in one or more departments including office space, work stations, equipment, and office supplies. 6. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 7. Manages and coordinates training sessions for assigned departments when new policies or practices are adopted. 8. Ensures compliance with University and federal regulations as they apply to the assigned departments. 9. Identifies, plans, and develops administrative policies for the assigned departments. 10. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 11. Assesses and makes recommendations regarding staff development and staffing levels. 12. Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis. 13. Manages a staff of exempt and non-exempt employees. 14. May perform other duties as assigned. Required Education and Experience Bachelor’s Degree in related field and 5 years of experience or an equivalent combination of education and related experience.

Job Posting Date

09/11/2026

Job Category

Manager

Bargaining Unit

NON

Compensation Grade

Administration & Operations

Compensation Grade Profile

Manager; Program Leader (25)

Salary Range

$82,000.00 - $131,500.00

Time Type

Full time

Duration Type

Staff

Work Model

Remote

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks basedon the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

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.