Regulatory Project Manager
Reporting to the Senior Regulatory Project Manager, the Regulatory Manager is tasked with maintaining quality control functions and monitoring compliance for research studies supported by the regulatory affairs department and involved with proactively addressing issues to ensure overall integrity in document management through quality and compliance checks. Working collaboratively with key stakeholders within YCC Clinical Trials Office (CTO), as well as colleagues across the YCC research enterprise, this role will oversee assigned service lines (workflow processes) and track regulatory activation milestones and timelines, promoting timely and compliant opening of new studies, in addition to providing administrative oversight of clinical trials by actively monitoring approvals, document creation, sponsor relationships, and overall study management from a regulatory perspective.
- Supervise day to day work activities of assigned regulatory staff, including delegation of work units and managing staff workload through communication of job expectations, planning, monitoring, and evaluation of work product.
- Provide quality reviews and oversight functions for all institutional review board (IRB) submissions and post-approvals to ensure regulatory integrity, while evaluating submission metrics and staff feedback to identify gaps in efficiency.
- Manage regulatory compliance activities related to quality control, including audit preparation, responses related to regulatory findings, reportable events, corrective actions, and other special projects related to efficiency and compliance within the regulatory department.
- Under direction of the Senior Regulatory Project Manager, develop new regulatory policies, processes and SOPs/guidance documents, and evaluate existing policies and procedures by performing quality control checks and collaborating with University quality assurance personnel.
- Conduct and assist in leading regulatory quality control activities for Investigator-Initiated, Industry sponsored, and national Cooperative group studies.
- Conduct ongoing quality reviews of regulatory binders and study related activities in preparation for internal and external audits and/or inspections.
- Maintain regulatory compliance and project management for single-center Investigator-Initiated Clinical Trials where the IND is held by a Yale Investigator. Liaise with IND Coordinator to ensure compliance with Code of Federal Regulations.
- Identify resource requirements for pipeline protocols and forecast logistical issues that affect regulatory compliance.
- Facilitate and track data with the flow of pipeline protocols throughout the start-up process. Identify regulatory obstacles to study activation and propose improvements to the process, analyze activation barriers, and report to senior research leadership activation metrics, potential roadblocks to success, and corrective actions.
- Perform staff coaching, mentoring, progressive counseling, and disciplining, as needed. Provide performance feedback and performance management as indicated.
- Participate in and lead structured meetings including (but not limited to) Regulatory Staff Meetings, education for Regulatory Staff, and special project sessions which facilitate communication, knowledge dissemination, process improvement, and general regulatory topics.
- Maintain and advance professional knowledge on appropriate regulations and processes related to regulatory compliance in clinical trials, as well as attend educational workshops, review professional publications, and disseminate knowledge to group.
- Apply strong attention to detail in all aspects of regulatory work.
- Other duties as assigned.
- 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 three years of related experience or an equivalent combination of education and experience.
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 2:
Ability to prioritize the oncology-specific workload of a large, multi-study portfolio, with multiple DART-specific responsibilities.
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.
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 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.
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.
Preferred Licenses or Certifications:
ACRP/SoCRA (or equivalent) certification preferred; Master’s level preparation preferred.
Weekend Hours Required? Occasional
Evening Hours Required? Occasional
Drug Screen No
Health Screening No
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: firstname.lastname@example.org.
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