Clinical Research Manager

Yale University; New Haven (CT); Hybrid; USD 68,000 - 121,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Yale University in New Haven seeks a Clinical Research Manager within the Yale Cancer Center's Clinical Trials Office to lead oncology trial operations and supervise staff across the Smilow Care Centers. This role requires strong leadership, a deep understanding of GCP, and a commitment to participant safety.

The position emphasizes recruiting, performance management, and collaboration with multidisciplinary teams to ensure protocol adherence and high-quality trial conduct.

Qualifications

• Bachelor’s degree in health-related discipline and minimum five years of experience in clinical trials.
• Strong leadership and people-management capabilities with the ability to recruit, retain, and develop staff.
• Detailed knowledge of Good Clinical Practice (GCP) and ability to interpret applicable guidelines and policies.

Responsibilities

• Manage policies, practices, and procedures of clinical research staff for protocol-driven trials.
• Recruit, hire, and evaluate staff; assign workloads and monitor staffing needs.
• Serve as protocol management expert; develop and maintain trial materials and logs.
• Collaborate with CTO Project Manager and PIs on complex oncology trials; act as liaison with sponsors and regulators.
• Ensure infrastructure and resources meet trial needs while safeguarding participant safety.
• Ensure compliance with federal/state regulations and SOPs; support audits and inspections.
• Contribute to SOP updates and staff training; coordinate cross-departmental activities.
• Lead site initiation, monitoring visits, and ongoing trial operations.

Skills

Communication & leadership

Trial infrastructure

GCP knowledge

Ethical conduct & confidentiality

Project management

Education

Bachelor’s degree in health-related discipline

Job description

Department: Comprehensive Cancer Center - Clinical Trial Operations

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

Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available with 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research prevention, and patient care, as well as community outreach and education.

Working under the direction of the Assistant Director for Clinical Operations, the Clinical Research Manager (CRM) is responsible for managing the Oncology Disease Group or Smilow Care Center staff members within the Clinical Trials Office (CTO) of Yale Cancer Center (YCC) and ensures appropriate infrastructure to conduct clinical trials in accordance with the study protocol and applicable policies and regulation while ensuring participant safety. This position requires a strong emphasis on people management, including staff recruitment, retention, and performance management to ensure quality, accountability and growth. Works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism.

Required Skills and Abilities

• 1. Strong communication, leadership, and team-building skills, including resource management and effective problem-solving.


• 2. Ability to assess and ensure appropriate infrastructure for clinical trials, considering clinical, physical, technological, and staff resources.


• 3. Extensive knowledge of Good Clinical Practice guidelines and the ability to interpret federal, state, and institutional policies and complex clinical trial protocols.


• 4. Proactive, flexible, and customer-focused, with a commitment to ethical conduct and participant confidentiality.


• 5. Ability to manage multiple projects simultaneously, balancing priorities and deadlines, and reporting on project deliverables effectively.

Preferred Skills and Abilities

• 1. Demonstrated experience supervising staff.


• 2. Experience with oncology clinical trials.


• 3. ACRP/SOCRA (or equivalent) certification preferred, with willingness to obtain within one year.

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

Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available with 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research prevention, and patient care, as well as community outreach and education.

Working under the direction of the Assistant Director for Clinical Operations, the Clinical Research Manager (CRM) is responsible for managing the Oncology Disease Group or Smilow Care Center staff members within the Clinical Trials Office (CTO) of Yale Cancer Center (YCC) and ensures appropriate infrastructure to conduct clinical trials in accordance with the study protocol and applicable policies and regulation while ensuring participant safety. This position requires a strong emphasis on people management, including staff recruitment, retention, and performance management to ensure quality, accountability and growth. Works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism.

Required Skills and Abilities

• 1. Strong communication, leadership, and team-building skills, including resource management and effective problem-solving.


• 2. Ability to assess and ensure appropriate infrastructure for clinical trials, considering clinical, physical, technological, and staff resources.


• 3. Extensive knowledge of Good Clinical Practice guidelines and the ability to interpret federal, state, and institutional policies and complex clinical trial protocols.


• 4. Proactive, flexible, and customer-focused, with a commitment to ethical conduct and participant confidentiality.


• 5. Ability to manage multiple projects simultaneously, balancing priorities and deadlines, and reporting on project deliverables effectively.

Preferred Skills and Abilities

• 1. Demonstrated experience supervising staff.


• 2. Experience with oncology clinical trials.


• 3. ACRP/SOCRA (or equivalent) certification preferred, with willingness to obtain within one year.

Principal Responsibilities

• 1. Manages and monitors policies, practices and procedures of clinical research staff responsible for the implementation, management (including protocol updates / amendments), and quality conduct of clinical trials according to study protocols and Good Clinical Practice guidelines.


• 2. Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research staff. Assigns and manages workload and provides estimates for individual project staffing needs using the Staffing Acuity Tool. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters.


• 3. Serves as a subject matter expert on protocol management and study subject recruitment. Provides support and guidance to the study team to develop and maintain study specific materials (e.g., tracking logs, templates, monitoring tools, source documents, study binders, process manuals).


• 4. Collaborates with CTO Clinical Trials Project Manager and Principal Investigator (PI) on assessment and operational implementation of highly complex trials clinical research protocols within Oncology Disease Group, including feasibility, identifying accrual targets, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process. Serves as a liaison to the study sponsor, regulatory agencies, investigators, and clinical teams.


• 5. Ensures infrastructure to conduct clinical trials by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies and regulations while ensuring participant safety. Includes assigning research support staff.


• 6. Manages oversight of protocol conduct and ensures that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines. Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements and follows directives that may be required to ensure University compliance with congruency review and reporting requirements.


• 7. Develops, implements, and champions internal practices that ensure compliance with federal requirements.


• 8. Serves as a critical resource before and during interim monitoring visits, internal audits and external audits/inspections. Works with study monitors to ensure compliance with study requirements. Analyzes and interprets reports/findings from retro/prospective audits with investigators and advises and monitors appropriate action plan. Responsible for contributing to formal responses to audit and inspection report findings that relate to clinical operations findings.


• 9. Contributes to the review and refinement of CTO standard operating procedures (SOPs) and assists with SOP training.


• 10. Coordinates with Clinical Trials Project Manager to liaise between clinical and non-clinical related departments to resolve congruency issues in a timely manner for protocols/projects within their assigned Oncology Disease Group or Smilow Care Center.


• 11. Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring


• 12. Other duties as assigned

Required Education and Experience

Bachelor’s degree in a health-related discipline, or other related field and a minimum of five(5) years of experience in clinical trials research or the equivalent combination of education or experience

Job Posting Date

10/19/2026

Job Category

Manager

Bargaining Unit

NON

Compensation Grade

Administration & Operations

Compensation Grade Profile

Manager; Program Leader (M5)

Salary Range

$68,000.00 - $120,500.00

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

Hybrid

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

This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.

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.

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