Senior Regulatory Manager
Company: Yale University
Location: New Haven
Posted on: May 12, 2022
|
|
Job Description:
Position Focus: -Reporting to the Assistant Director, Regulatory
Affairs, the Senior Regulatory 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.Essential Duties: - 1. 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. 2. Manages the administrative support needs for exempt
and nonexempt staff and provides recommendations, improvements,
solutions and assistance as needed. 3. Manages and monitors
technology needs, conducts inventory, and system requirements for
the assigned departments. 4. Develops and prepares budgets,
financial forecasts, and financial analyses and the actual vs.
budgeted performance reports for the departments. 5. Manages the
use of facilities in one or more departments including office
space, work stations, equipment, and office supplies. 6. Manages
administrative support for activities of one or more departments to
ensure timely completion of projects. 7. Manages and coordinates
training sessions for assigned departments when new policies or
practices are adopted. 8. Ensures compliance with University and
federal regulations as they apply to the assigned departments. 9.
Identifies, plans, and develops administrative policies for the
assigned departments. 10. Assists in reviewing and implements
University and departmental policies as they pertain to the
administrative functions of the assigned department. 11. Assesses
and makes recommendations regarding staff development and staffing
levels. 12. Monitors, develops, plans, and executes systematic
research on user requirements through such mechanisms as surveys,
interviews, focus groups and competitive analysis. 13. Manages a
staff of exempt and non-exempt employees. 14. 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.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.Required Skill/Ability: -1) -Ability to clearly
communicate and understand written information.2) -Ability to
analyze ideas, use logic, and recognize the nature of issues to
develop creative problem-solving opportunities.3) -Ability to
motivate, develop, and assess learning capacity of direct reports.
-Weekend Hours Required? OccasionalEvening Hours Required?
-OccasionalBackground 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.COVID-19 Vaccine Requirement: Please note that the
university has a -. For up-to-date information -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
duties and responsibilities of the particular position. Employees
will be assigned specific job-related duties through their hiring
departments.
Keywords: Yale University, New Haven , Senior Regulatory Manager, Executive , New Haven, Connecticut
Click
here to apply!
|