Clinical Trials Manager

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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

1. Excellent written and verbal communication skills, with strong attention to detail.

2. Proven experience conducting and supporting all phases of clinical research, including data management and analysis. Phlebotomy.

3. Strong organizational skills, with the ability to multitask, prioritize tasks, and manage time effectively across multiple clinical trials.

4. 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.

5. Proficiency in Microsoft Office Suite and experience with electronic data collection tools.

Preferred Skills and Abilities

1. Master's degree in a related field (e.g., public health, social sciences).

2. Proven experience preparing IRB protocols, amendments, and progress reports.

3. Proven experience with clinical trials, including patient recruitment and regulatory submissions.

4. Familiarity with statistical analysis software (e.g., SPSS, SAS, R).

5. Prior experience working on large-scale research studies or multi-visit projects.

Principal Responsibilities

1. Carries 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. 2. Develops criteria for admission of study subjects based on goals and objectives of project. 3. Determines potential sources of funding and prospective partnerships. 4.

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. 5. 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. 6.

Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding. 7. 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. 8. 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. 9.

Performs descriptive and multivariate statistical analyses of data, using computer software. 10. Designs and implements quality control measures to ensure accurate collection and processing of data. 11. 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