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.
Preferred Education: A minimum of a BA/BS degree or equivalent with 5 years regulatory experience (e.g., research, clinical, interaction with study population, program coordination) and 3 years supervisory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Preferred Education, Experience and Skills: A minimum of a BA/BS degree or equivalent with 5 years regulatory experience (e.g., research, clinical, interaction with study population, program coordination) and 3 years supervisory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Required Skill/ability 5: Ability to motivate, develop, and assess learning capacity of direct reports, as well as identify opportunities to assess quality, efficiency, and implement process improvement in regulatory activities when necessary.
Posting Position Title: Manager 2
Required Skill/ability 3: Ability to maintain compliant processes and workflows supporting a large, multi-study oncology protocol portfolio. Ability to participate in and help lead quality control and educational efforts within a large oncology regulatory department. Strong attention to detail and quality in document and form submission.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Regulatory Manager 2
Required Skill/ability 1: Ability to lead regulatory personnel in a large, multi-study oncology-specific workload portfolio and assure compliance with regulatory agencies.
Required Skill/ability 4: Ability to interface with, communicate, and provide a large volume of compliant submissions for protocol activation and ongoing compliance to the oncology specific committees which govern Yale Cancer Center Human Subject research studies.
Required Skill/ability 2: Ability to prioritize the oncology-specific workload of a large, multi-study portfolio, with multiple DART-specific responsibilities.
Bachelor's Degree in related field and three years of related experience or an equivalent combination of education and experience.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.