Regulatory Affairs Manager

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Overview

The Regulatory Affairs Manager is responsible for managing Oncology Disease Group regulatory affairs teams within the Clinical Trials Office (CTO) of Yale Cancer Center (YCC) and ensures appropriate infrastructure to support clinical trials regulatory requirements in accordance with the IRB approved study protocol and applicable policies and regulations. 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. Demonstrated communication, leadership and team building skills: evidence of this should include resource management, effective problem solving, conflict resolution, motivating others as individuals and as groups, and planning, organizing, and directing the activities of others. Proven ability to manage and monitor the policies, practices, and procedures of staff. Proven ability to develop specific short- and long-term objectives for staff.

2. Expert ability to lead, organize, and execute complex projects; multi-task, identify, analyze, and resolve problems efficiently and effectively; use independent good judgment and to assess risk. Independently follow through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.

3. Strong demonstrated ability to ensure appropriate infrastructure by evaluating the regulatory, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies, and regulations. Demonstrated ability to report on the status of project deliverables and draft and submit project updates to Yale Cancer Center team and study sponsor.

4. Strong knowledge of Good Clinical Practice guidelines. Proven experience interpreting federal, state, Yale University and sponsor policies and regulations. Experience with interpreting complex oncology clinical trial protocols and federal, state, local guidelines.

5. Demonstrated ability to provide proactive, flexible, and customer service focused advice; work effectively with others; and demonstrate ethics and integrity in a professional manner, sensitivity to confidentiality, and a commitment to protecting research participants.

Preferred Skills and Abilities

1. Master’s degree in a health-related discipline, or other related field.

2. Experience with oncology clinical trials is strongly preferred.

Preferred Licenses or Certifications

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

Principal Responsibilities

• Manages and monitors policies, practices, and procedures of Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1 responsible for the management of study portfolios and the execution of regulatory activities for all types of clinical research studies across the lifecycle of the protocol from activation to closeout according to Good Clinical Practice guidelines and applicable federal regulations.
• Responsible for recruiting, hiring, training plans, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1). Assigns and manages workload and provides estimates for individual project staffing needs. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters.
• Collaborates with CTO Clinical Research Managers, Project Managers and Principal Investigator (PI) on assessment of highly complex trials clinical research protocols including feasibility, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process.
• Collaborates with CTO Assistant Director for Regulatory Affairs to oversee preparation for regulatory agency and sponsor audits and inspections.
• Ensures infrastructure to support requirements for clinical trials by evaluating the regulatory, technological, and staff resources required to ensure each clinical trial can be supported in accordance with the study protocol, applicable policies, and regulations. Includes assigning regulatory affairs staff (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1).
• Collaborates with CTO leadership to develop annual measurable goals and objectives for the CTO; measures progress against those goals to report to Assistant Director for Regulatory Affairs.
• Collaborates with CTO Assistant Director for Regulatory Affairs and Quality and Education unit to determine the best approach for utilizing technology solutions to support clinical research regulatory processes.
• Partners with the CTO Quality and Education unit to ensure proper education and training of regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1) as it pertains to regulatory responsibilities. In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees.
• Participates in performance improvement activities by contributing ideas, experience, and expertise to promote efficiency and quality outcomes for the institution and the department. Continually identifies opportunities for improvement or enhancement in regulatory processes based on experience and information acquired from other programs, professional associations, review publications and conferences.
• Provides a lead role in developing and coordinating departmental policies and procedures to ensure the efficient regulatory operation of clinical trials.
• Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements, assesses impact of changes to regulations and policies, and follows directives that may be required to ensure University compliance with congruency review and reporting requirements.
• Develops, implements, and champions internal practices that ensure compliance with federal requirements.
• Identifies, facilitates, and coordinates with the Quality and Education team quality improvement activities including conducting internal quality reviews, analyzing results, and identifying trends that would indicate educational needs.
• Other duties as assigned.


Required Education and Experience

Bachelor’s degree in a health-related discipline and a minimum of seven (7) years of clinical research experience or the equivalent combination of education or experience. Five (5) years of regulatory affairs experience required.

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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 based on 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 through their 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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