Clinical Trials Manager

Department: Internal Medicine - Digestive Diseases

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Overview

The Clinical Trials Manager (CTM) will manage the research program for the Autoimmune and Cholestatic Liver Disease Program at Yale. The CTM will manage multiple principle investigators and potentially multiple other sites for collaborative research. This position will manage all aspects of this clinical trials program which may include collaborating in the development of the research protocols required for study. This position will foster and maintain relationships with all investigators and faculty involved in this clinical trials program. The CTM will be responsible for outreach efforts to expand the referrals of new patients for tertiary patient care as well as participation in these cutting edge studies on both a regional and national level. This position is responsible for compiling, analyzing and reporting the data to the sponsors on a regular basis. The CTM may use this analyzed data for presentations and publications as well. The CTM will be responsible for the administration, organization and execution of all clinical research.

The CTM may need to build a budget without assistance from sponsor or principle investigators by researching similar trials and contacting appropriate sources for additional data required. The best candidate for this position would have an extensive background in clinical trials with a demonstrated knowledge of medicine and biology. This education would allow the candidate to comprehend and interpret laboratory work received and permit the candidate to fully understand the research being conducted. This clinical knowledge will also assist the candidate in determining which subjects would be best suited for the trials when recruiting patients. In order to develop the program the CTM will be required to create original HIC and IRB submissions; collaborate with principle investigators an the creation and maintenance of all scientific protocols based on previous knowledge; implement any protocol changes; design and implement quality control measures to ensure the accurate collection of data; contribute original scientific thoughts for written reports, abstracts, manuscripts, and publications.

Job Summary:

Participates in the design, administration, and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives. Manages various aspects of research projects, including patient recruitment, data collection, and ensuring adherence to regulatory standards. Provides team support on research projects, ensuring meticulous data management, and assisting in the preparation of reports and publications.

Required Skills and Abilities

• Excellent written and verbal communication skills, with strong attention to detail.
• Proven experience conducting and supporting all phases of clinical research, including data management and analysis. Phlebotomy.
• Strong organizational skills, with the ability to multitask, prioritize tasks, and manage time effectively across multiple clinical trials.
• Proven experience with participant interaction, IRB submissions, and initiation and maintenance of human research studies and ability to work both independently and as part of a multidisciplinary team.
• Proficiency in Microsoft Office Suite and experience with electronic data collection tools.

Preferred Skills and Abilities

• Master's degree in a related field (e.g., public health, social sciences).
• Proven experience preparing IRB protocols, amendments, and progress reports.
• Proven experience with clinical trials, including patient recruitment and regulatory submissions.
• Familiarity with statistical analysis software (e.g., SPSS, SAS, R).
• Prior experience working on large-scale research studies or multi-visit projects.

Principal Responsibilities

• Carriers out research within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies.
• Develops criteria for admission of study subjects based on goals and objectives of project.
• Determines potential sources of funding and prospective partnerships.
• Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group. Negotiates contracts and/or changes with funder.
• Develops original HIC/IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols. Plans and implements changes.
• Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding.
• Responsible for the documentation and transmission of study data. Ensures that report forms are accurately documented and completed in a timely manner at each site location.
• Works independently to develop manage and organize multi site studies. Serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources.
• Performs descriptive and multivariate statistical analyses of data, using computer software.
• Designs and implements quality control measures to ensure accurate collection and processing of data.
• Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.

Required Education and Experience

Master’s Degree in a related discipline and two years of experience or an equivalent combination of education and experience.

Required License(s) or Certification(s)

Required License(s) or Certification(s):

Physical Requirements

Physical Requirements:

Job Posting Date

10/21/2026

Job Category

Professional

Bargaining Unit

NON

Compensation Grade

Clinical & Research

Compensation Grade Profile

Research Associate 2 HSS (23)

Salary Range

$65,000.00 - $101,000.00

Benefits

A general description of the benefits to be offered with this Managerial & Professional position is available at:

Yale Benefits

Time Type

Full time

Duration Type

Staff

Work Model

On-site

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).

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