Senior Regulatory Project Manager
Reporting to the Assistant Director, Regulatory Affairs, the Senior Regulatory Project Manager is tasked with oversight and governance of the regulatory affairs department and involved in the day-to-day support of the clinical research studies conducted at the Yale Cancer Center (YCC). Working collaboratively with key stakeholders within YCC Clinical Trials Office (CTO), as well as colleagues across the YCC and YCCI research enterprise, this role advocates for the advancement of critical strategic objectives that promote effective, efficient, and compliant management of clinical studies.
Oversee and manage the assigned recognized organizational program and lead day-to-day program operations and administration.
Interface with department leaders across the organization and other partners in the administration of the program. Identify and define any logistics, action items or information needed to maintain operations.
Identify growth opportunities and further efficiencies that impact the program and/or departments success and aid in development of strategic plans to achieve objectives. Interface with internal/external stakeholders to maintain and further develop program growth, community outreach activities, as well as relationship building and maintenance.
Plan, develop, coordinate, and organize resources to meet program objectives; responsible for identifying program participants and lead cross-functional teams in the administration, maintenance or expansion of the program.
Create and foster a collaborative, positive relationship with internal staff and external agencies/organizations.
Responsible for developing and implementing any applicable education, training, on-boarding and/or mentorship pertaining to the program.
In conjunction with leadership, responsible for planning and managing program fiscal budgets and financials.
Ensure compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintain staff and program compliance with organizational policies and procedures.
Research, acquire, organize and summarize data for evaluating performance of program or other program operations. Develop, evaluate, recommend and implement procedures for data acquisition, management and quality control. Analyze data for trends or conclusions and presents results and recommendations to senior leadership.
Provide leadership, direction and strategic planning for clinical research operations within the department, including direct oversight of regulatory activities supporting clinical studies, anticipating and implementing changes in regulations governing clinical research, and planning for the regulatory aspects of growth to support the research portfolio, site-specific disease research groups, Investigators, and Network/Affiliate research facilities.
Directly manage and supervise the department personnel. In collaboration with leadership, responsible for performing staff recruitment, screening, interviewing, hiring, performance evaluations, and counseling activities for the department.
Develop goals for direct reports to foster professional growth and complete annual performance reviews following the Human Resource (HR) procedures. In addition, routinely monitor and evaluate staff performance during the annual review period and provide constructive and meaningful assessments on their performance.
Monitor department personnel workload intensity and track deadlines to ensure timely submission and/or completion and appropriate regulatory reporting and compliance are met. Promote design, development, implementation, and assessment of sustainable workflows/solutions that will support the compliant conduct of clinical studies. Supply requisite metrics for departmental meetings and Cancer Center leadership at established frequency.
- Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department of the University.
- Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions and assistance as needed.
- Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments.
- Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments.
- Manages the use of facilities in one or more departments including office space, work stations, equipment, and office supplies.
- Manages administrative support for activities of one or more departments to ensure timely completion of projects.
- Manages and coordinates training sessions for assigned departments when new policies or practices are adopted.
- Ensures compliance with University and federal regulations as they apply to the assigned departments.
- Identifies, plans, and develops administrative policies for the assigned departments.
- Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department.
- Assesses and makes recommendations regarding staff development and staffing levels.
- Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis.
- Manages a staff of exempt and non-exempt employees.
- May perform other duties as assigned.
Required Education and Experience
Bachelor’s Degree in related field and 5 years of experience or an equivalent combination of education and related experience.
Required Skill/Ability 1:
Ability to clearly communicate and understand written information.
Required Skill/Ability 2:
Ability to analyze ideas, use logic, and recognize the nature of issues to develop creative problem-solving opportunities.
Required Skill/Ability 3:
Ability to motivate, develop, and assess learning capacity of direct reports.
Preferred Education, Experience and Skills:
BA/BS degree or equivalent with minimum of 5 years direct regulatory supervisory experience, plus 7 years of regulatory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.
Preferred Licenses or Certifications:
ACRP/SoCRA (or equivalent) certification preferred. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.
Weekend Hours Required?
Evening Hours Required?
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. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
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 particular position. Employees will be assigned specific job-related duties through their hiring departments.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: email@example.com.
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