Regulatory Affairs Manager
Comprehensive Cancer Center - Clinical Trial Operations
Salary Range
MP 26 $81,500-$142,000 with sign on bonus potential
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Position Focus:
Reporting to the Assistant Director for Regulatory Affairs, the Regulatory Affairs Manager is responsible for managing Oncology Disease Group regulatory affairs teams within the Clinical Trials Office (CTO) of Yale Cancer Center (YCC) and ensures appropriate infrastructure to support clinical trials regulatory requirements in accordance with the IRB approved study protocol and applicable policies and regulations. This position requires a strong emphasis on people management, including staff recruitment, retention, and performance management to ensure quality, accountability, and growth. Works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism.
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 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.
Essential Duties
Manages and monitors policies, practices, and procedures of Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1 responsible for the management of study portfolios and the execution of regulatory activities for all types of clinical research studies across the lifecycle of the protocol from activation to closeout according to Good Clinical Practice guidelines and applicable federal regulations. Responsible for recruiting, hiring, training plans, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1). Assigns and manages workload and provides estimates for individual project staffing needs. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters. Collaborates with CTO Clinical Research Managers, Project Managers and Principal Investigator (PI) on assessment of highly complex trials clinical research protocols including feasibility, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process. Collaborates with CTO Assistant Director for Regulatory Affairs to oversee preparation for regulatory agency and sponsor audits and inspections. Ensures infrastructure to support requirements for clinical trials by evaluating the regulatory, technological, and staff resources required to ensure each clinical trial can be supported in accordance with the study protocol, applicable policies, and regulations. Includes assigning regulatory affairs staff (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1). Collaborates with CTO leadership to develop annual measurable goals and objectives for the CTO; measures progress against those goals to report to Assistant Director for Regulatory Affairs. Collaborates with CTO Assistant Director for Regulatory Affairs and Quality and Education unit to determine the best approach for utilizing technology solutions to support clinical research regulatory processes. Partners with the CTO Quality and Education unit to ensure proper education and training of regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1) as it pertains to regulatory responsibilities. In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees. Participates in performance improvement activities by contributing ideas, experience, and expertise to promote efficiency and quality outcomes for the institution and the department. Continually identifies opportunities for improvement or enhancement in regulatory processes based on experience and information acquired from other programs, professional associations, review publications and conferences. Provides a lead role in developing and coordinating departmental policies and procedures to ensure the efficient regulatory operation of clinical trials. Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements, assesses impact of changes to regulations and policies, and follows directives that may be required to ensure University compliance with congruency review and reporting requirements. Develops, implements, and champions internal practices that ensure compliance with federal requirements. Identifies, facilitates, and coordinates with the Quality and Education team quality improvement activities including conducting internal quality reviews, analyzing results, and identifying trends that would indicate educational needs. Other duties as assigned.
Required Education and Experience
Bachelor’s degree in a health-related discipline and a minimum of seven (7) years of clinical research experience or the equivalent combination of education or experience. Five (5) years of regulatory affairs experience required. Three (3) years of supervisory experience required.
Required Skill/Ability 1:
Demonstrated communication, leadership and team building skills: evidence of this should include resource management, effective problem solving, conflict resolution, motivating others as individuals and as groups, and planning, organizing, and directing the activities of others. Proven ability to manage and monitor the policies, practices, and procedures of staff.
Required Skill/Ability 2:
Expert ability to lead, organize, and execute on complex projects; multi-task, identify, analyze, and resolve problems efficiently and effectively; use independent good judgment and to assess risk. Independently follow through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.
Required Skill/Ability 3:
Demonstrated ability to ensure appropriate infrastructure by evaluating the regulatory, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the protocol, applicable policies, and regulations. Ability to report on the status of project deliverables and draft and submit project updates to the team and study sponsor.
Required Skill/Ability 4:
Strong knowledge of Good Clinical Practice guidelines. Proven experience interpreting federal, state, Yale University and sponsor policies and regulations. Experience with interpreting complex oncology clinical trial protocols and federal, state, local guidelines.
Required Skill/Ability 5:
Demonstrated ability to provide proactive, flexible, and customer service focused advice; work effectively with others; and demonstrate ethics and integrity in a professional manner, sensitivity to confidentiality, and a commitment to protecting research participants.
Preferred Education, Experience and Skills:
Master's degree in a health-related discipline, or other related field. Experience with oncology clinical trials strongly preferred.
Preferred Licenses or Certifications:
ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.