Assistant Director, Clinical Trials Operations

Yale Cancer Center; New Haven, Northern (CT, KY); Hybrid; USD 90,000 - 166,000; Full time

Benefits offered by this job

ACRP/SOCRA certification preferred

Job summary

Yale Cancer Center in New Haven is seeking an Assistant Director, Clinical Trial Operations to lead the CTO oncology disease group portfolio. The role oversees day-to-day operations, staff development, and strategic planning to improve productivity, compliance, and patient satisfaction.

Reporting to the CTO Operations Director, you will manage clinical research professionals, coordinate audits, and ensure timely activation of trials while maintaining high standards of regulatory compliance and

Qualifications

• Demonstrated mastery of the phases of clinical trials, and the regulatory, administrative, and operational functions necessary to support the clinical research study life cycle in a safe and compliant manner.
• Proven ability to manage and evaluate orientation, education and professional developmental needs for research staff using CFR, GCP, ICH, protocol requirements, and research professional resources with the objective of developing and maintaining high functioning of clinical research experts.
• Ability to conduct periodic reviews of the clinical trial portfolio and evaluate the research infrastructure to ensure best use of resources and clinical trial accrual. Demonstrated ability auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance.
• Understanding of clinical research operations. Ability to assist with achieving financial and, operations targets for assigned research areas through participation in program planning, budget development, and development of operational practices.
• Communication, leadership and team building skills: evidence of this should include resource management, effective problem solving, conflict resolution, and planning, organizing, and directing the activities of others. Provides leadership and promotes collaboration, including the proven ability to work effectively with staff, faculty, senior management, and team members.

Responsibilities

• Directs and oversees the clinical trial operation function for Yale Cancer Center, CTO oncology disease group. Creates objectives for the portfolio and develops budgets, policies and procedures.
• Provides strategic input to leadership related to short and long-term planning for the Cancer Center CTO. Develops objectives for productivity, compliance, communication and patient satisfaction.
• Designs and implements process improvement initiatives to meet goals and objectives.
• Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research professionals.
• Establishes priorities with timelines to ensure efficient operations. Deploys resources among teams with disease group leaders.
• Partners with CTO Quality and Education unit to ensure education and training of clinical research professionals and develops role-based curricula.
• Ensures full compliance of clinical research operations and prepares responses to audit findings.
• Drives operational changes to achieve best-in-class operations and ensures CTRP compliance.
• Manages data management functions and collaborates with external sponsors on data collection platforms.
• Oversees activation of clinical trials from protocol concept to accrual status and monitors protocol activation.

Skills

Mastery of clinical trials phases

Staff training & development

Audits & regulatory compliance

Clinical research operations

Communication & leadership

Education

Bachelor’s degree in health-related discipline

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!

Salary Range

$90,000.00 - $165,750.00

Job Requisition ID

138491WD

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 within 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.

Yale Cancer Center is seeking a dynamic Assistant Director, Clinical Trial Operations to lead a portfolio of clinical research oncology disease groups in the Clinical Trials Office. Working under the Director of CTO Operations, the Assistant Director will assist cancer center leadership in achieving its research mission and strategic initiatives, by serving as a direct link between the clinical research disease team staff, the CTO administration, and Smilow Cancer Hospital. The incumbent will provide consistent leadership for the day-to-day operations of the clinical research disease programs, ensure competent and standardized staff practices, and coordinate strategies to enhance interdisciplinary communication and collaboration.

Essential Duties

Directs and oversees the clinical trial operation function for a Yale Cancer Center, Clinical Trials Office oncology disease group. Creates functional strategies and specific objectives for the assigned oncology disease group portfolio and develops budgets, policies and procedures to support the functional infrastructure. Provides strategic input to leadership related to short and long-term planning for the Cancer Center Clinical Trials Office. Develops and implements short and long-term objectives for assigned portfolio related to productivity, compliance, communication and patient satisfaction. Designs and implements process improvement initiatives to meet goals and objectives. Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research professionals (clinical research managers, clinical trials project managers, data coordinators, clinical research coordinators, and clinical research nurses. Establishes priorities with appropriate timelines for to ensure efficient and effective operations. Deploys resources among teams in collaboration with faculty oncology disease group leaders. Partners with the CTO Quality and Education unit to ensure proper education and training of clinical research professionals (data coordinators, clinical research coordinators, clinical research nurses and clinical research managers) as it pertains to clinical facing responsibilities. In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees. Ensures full compliance of clinical research operations within the span of authority of the position. Prepares responses to audit findings. Designs, implements, and monitors corrective action plans. Drives operational changes to achieve best in class operations throughout the organization based on the findings of internal or external auditors, confirming full compliance of requirements of Clinical Trials Reporting Program (CTRP). Manages and directs the data management functions inherent to oncology clinical research of assigned disease team portfolios, including effectively and efficiently collaborating with external sponsors on requisite data collection platforms. Oversees the activities necessary to ensure effective and timely activation of clinical trials within disease team portfolio from stage of protocol concept through obtaining open to accrual status. Utilizes data to effectively monitor the process for protocol activation.

Required Skills and Abilities

1. Demonstrated mastery of the phases of clinical trials, and the regulatory, administrative, and operational functions necessary to support the clinical research study life cycle in a safe and compliant manner.
2. Proven ability to manage and evaluate orientation, education and professional developmental needs for research staff using the CFR, GCP, ICH, protocol requirements, and research professional resources with the objective of developing and maintaining high functioning of clinical research experts.
3. Ability to conduct periodic reviews of the clinical trial portfolio and evaluate the research infrastructure to ensure best use of resources and clinical trial accrual. Demonstrated ability auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance.
4. Understanding of clinical research operations. Ability to assist with achieving financial and, operations targets for assigned research areas through participation in program planning, budget development, and development of operational practices.
5. Communication, leadership and team building skills: evidence of this should include resource management, effective problem solving, conflict resolution, and planning, organizing, and directing the activities of others. Provides leadership and promotes collaboration, including the proven ability to work effectively with staff, faculty, senior management, and team members.

Preferred Skills and Abilities

Master’s degree in a health-related discipline, or other related field. Experience with oncology clinical trials strongly preferred.

Preferred Licenses or Certifications:

ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.

Principal Responsibilities

• Directs and oversees the clinical trial operation function for a Yale Cancer Center, Clinical Trials Office oncology disease group. Creates functional strategies and specific objectives for the assigned oncology disease group portfolio and develops budgets, policies and procedures to support the functional infrastructure.
• Provides strategic input to leadership related to short and long-term planning for the Cancer Center Clinical Trials Office. Develops and implements short and long-term objectives for assigned portfolio related to productivity, compliance, communication and patient satisfaction.
• Designs and implements process improvement initiatives to meet goals and objectives.
• Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research professionals (clinical research managers, clinical trials project managers, data coordinators, clinical research coordinators, and clinical research nurses.
• Establishes priorities with appropriate timelines for to ensure efficient and effective operations. Deploys resources among teams in collaboration with faculty oncology disease group leaders.
• Partners with the CTO Quality and Education unit to ensure proper education and training of clinical research professionals (data coordinators, clinical research coordinators, clinical research nurses and clinical research managers) as it pertains to clinical facing responsibilities. In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees.
• Ensures full compliance of clinical research operations within the span of authority of the position. Prepares responses to audit findings. Designs, implements, and monitors corrective action plans.
• Drives operational changes to achieve best in class operations throughout the organization based on the findings of internal or external auditors, confirming full compliance of requirements of Clinical Trials Reporting Program (CTRP).
• Manages and directs the data management functions inherent to oncology clinical research of assigned disease team portfolios, including effectively and efficiently collaborating with external sponsors on requisite data collection platforms.
• Oversees the activities necessary to ensure effective and timely activation of clinical trials within disease team portfolio from stage of protocol concept through obtaining open to accrual status. Utilizes data to effectively monitor the process for protocol activation.

Required Education and Experience

Bachelor’s degree in a health-related discipline and a minimum of eight (8) years of clinical research experience with four (4) years of clinical trials research operations experience required. Three (3) years of supervisory experience required.

Required License(s) or Certification(s)

Required License(s) or Certification(s):

Original Job Posting Date

09/22/2026

Job Category

Manager

Bargaining Unit

NON

Compensation Grade

Clinical & Research

Compensation Grade Profile

Assistant Director, Clinical Trials Operations (M6)

Time Type

Full time

Duration Type

Staff

Work Model

Hybrid

Location

2 Church Street South, New Haven, Connecticut

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

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 dutiesand responsibilities of the position. Employees will be assigned specific job-related duties throughtheir hiring department.

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale's Policy Against Discrimination and Harassment, 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.