Senior Regulatory Project Manager
Yale University Cancer Center Clinicals Office
Please apply using this direct link: https://bit.ly/63304BR
About the Yale Cancer Center Clinical Trials Office (CTO)
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 open and enrolling clinical trials and over 600 open clinical trials, providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education.
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.
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.
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.
Working at Yale
Yale University offers exciting opportunities for achievement and growth in New Haven, Connecticut. Conveniently located between Boston and New York, New Haven is the creative capital of Connecticut with cultural resources that include three major museums, a critically-acclaimed repertory theater, state-of-the-art concert hall, and world-renowned schools of Architecture, Art, Drama, and Music.
We invite you to discover the excitement, diversity, rewards and excellence of a career at Yale University. One of the country's great workplaces, Yale University offers exciting opportunities for meaningful accomplishment and true growth. Our benefits package is among the best anywhere, with a wide variety of insurance choices, liberal paid time off, fantastic family and educational benefits, a variety of retirement benefits, extensive recreational facilities, and much more.
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.