Essential Duties1. Manages and monitors policies, practices, and procedures of clinical trials project managers, responsible for the implementation, coordination, and evaluation of all administrative aspects of clinical trials conduct. 2. Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical trials project managers. Assigns and manages workload and provides estimates for individual project staffing needs. Tracks data and metrics to determine appropriate personnel resource allocation based on portfolio parameters. 3. Creates detailed project plans including timelines, budgets, and resource allocation to ensure successful project completion. 4. Serves as a subject matter expert on the development, implementation, and management of clinical trials processes in compliance with GCP, SOPs and relevant regulations. 5. Directs risk assessments, communication planning, development of performance metrics, and project entry criteria. Designs, develops, and executes communication systems to ensure effective exchange of information between project stakeholders, senior management, and staff. 6. Works closely with leadership, internal constituents & staff, ancillary committees, External Sponsors, and Contract Research Organizations (CROs) to resolve site-level barriers to activation and improve protocol activation timelines. Recommends project management process improvements to the CTO Leadership Team. 7. Collaborates with CTO leadership to develop annual measurable goals and objectives for the CTO; measures progress against those goals to report to the Director of CTO Operations. 8. Collaborates with Director of CTO Operations and Quality and Education unit to determine the best approach for utilizing technology solutions to support project management processes. 9. Consults with CTO Assistant Directors of Clinical Operations to ensure applicable, efficient, and effective research processes are in place across teams; makes innovative and thoughtful recommendations and improvements to increase efficiency while ensuring compliance.10. In partnership with the CTO Quality and Education unit, develops, implements, and evolves specific role-based curriculum and ongoing education for employees. 11. 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 clinical research processes based on experience and information acquired from other programs, professional associations, review publications and conferences. 12. Provides a lead role in developing and coordinating departmental policies and procedures to ensure the efficient operation of clinical trials.13. Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements 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. 14. 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. 15. Resolves complex project issues that involve representatives from multiple organizations. 16. Complies with standard policies and procedures. 17. Other duties as assigned.Required Education and ExperienceBachelor's degree in a health-related discipline and a minimum of seven (7) years of clinical research experience with three (3) years of clinical research operations experience required. Three (3) years of supervisory experience required.Weekend Hours Required?OccasionalEvening Hours Required?OccasionalDuration TypeRegularWork WeekStandard (M-F equal number of hours per day)Drug ScreenNoHealth ScreeningNoBackground Check RequirementsAll 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. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.Searchable Job FamilyClinical, Research Res Support, Research/SupportExternal Gateway Posting Date11-Mar-2024Total # of hours to be worked:37.5Position Focus: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.Working under the Director of Clinical Trials Office (CTO) Operations, the Senior Manager, Clinical Trials Project Management is responsible for managing the oncology disease group Clinical Trials Project Managers within the CTO of Yale Cancer Center (YCC). The Clinical Trials Project Management unit is responsible for the coordination, implementation, and evaluation of all site level administrative aspects of clinical trial conduct, including project management of study start up, amendments and study close out. The Senior Manager, Clinical Trials Project Management is responsible for personnel management, including staff recruitment, retention, and performance management to ensure quality, accountability, and growth, as well as working within a multidisciplinary environment with colleagues both internally and externally.Required Licenses or CertificationsACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.Preferred Education, Experience and Skills:Master's degree in a health-related discipline, or other related field. Demonstrated experience with oncology clinical trials strongly preferred.Posting DisclaimerThe 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.Compensation GradeAdministration & OperationsCompensation Grade ProfileSenior Manager; Senior Program Leader (26)Bargaining UnitNone - Not included in the union (Yale Union Group)Supervisory OrganizationComprehensive Cancer Center - Clinical Trial OperationsTime TypeFull timeRequired Skill/Ability 1:Demonstrated communication, leadership & team building skills: evidence of this should include resource management, effective problem solving, performance management, mentorship, conflict resolution, motivating others, and planning, organizing, and directing the activities of others. Proven ability to develop specific short- and long-term objectives for staff.Required Skill/Ability 2:Strong demonstrated ability to ensure appropriate infrastructure by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies, and regulation while ensuring participant safety.Required Skill/Ability 3:Strong knowledge of GCP 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. Demonstrated ability to report on the status of project deliverables and draft and submit project updates.Required Skill/Ability 4: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.Required Skill/Ability 5: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.NoteYale University is a tobacco-free campusCOVID-19 Vaccine RequirementThe University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:Wage RangesClick to see our Wage RangesWork ModelOn-site
