1. Develop long-term goals and strategic objectives for the entire research enterprise, including identifying, analyzing, and monitoring issues that affect growth, profitability, and productivity of the research enterprise. 2. Develop strategies to support the growth of novel Yale science and the strategic growth of industry and federal sponsored research across departments, and clinical and therapeutic units. Develop strategies to minimize risk and ensure regulatory compliance. 3. Develop and oversee clinical trials systems framework for clinical research portfolio management across Yale Medicine/YSM departments and YNHHS resources, including resource allocation methodologies. Work with departmental leadership to develop strategic initiatives to support planned portfolios, including operational and resource planning across department, unit and organizational boundaries. 4. Develop, maintain, and revise clinical research both IND and FDA Part 11 compliance-related policies, procedures and communication practices for the operation of YM and applicable affiliates and their related activities. Establish and oversee consistent process for financial monitoring and oversight of all related functions, and record-keeping system to document the ongoing operation of the system compliance infrastructure. 5. Promote collaborative efforts and goals with investigators and other Yale affiliates to define operational needs for clinical trial new and remedial staff, areas in need of additional resources and/or structure reorganizations. Collaborate with leadership to define budgetary and compliance needs as well as ensuring compliance with regulations and internal policies. 6. Manage the development and maintenance of Standard Operating Procedures for clinical trial workflow and monitor attainment of SOP objectives. 7. Support the Director and COO in developmental planning and monitoring progress of center operations to enhance productivity and support a robust clinical research portfolio with industry-sponsored research growth. 8. Direct the operations of the YCCI data management support in collaboration with YCAS and JDAT resources while achieving sustainability during expansion. Provide oversight of multisite project management resource and FDA data submission standards, and related clinical trial workflow for internal staff and external Yale clients. Oversee and direct the managerial workforce who hire, supervise and evaluate staff. 9. Develop and lead cross functional project teams to deliver strategic, complex initiatives with an emphasis on providing robust frameworks to enable increased strategic focus for clinical research and efficient program management. 10. Develop and direct unit responsible for the coordination of communication and expectations with/between PIs, faculty, research staff, nurses, departments, Chairs, industrial/external sponsors/funders and all divisions related to program evaluation and research growth. 11. Represent Yale in leadership roles with internal process owners, service providers and other regulatory bodies. Serve as liaison to leadership, officers and other key internal and external collaborators with respect to the clinical research growth portfolio management, and programs. Develop new transformative, strategic, complex cross-institutional and national initiatives. 12. Foster an engaging environment for employees through talent acquisition, coaching, performance management, and training. 13. Interpret and monitor external and internal factors influencing goals. Drive leadership decisions in prioritizing and planning new programs or program changes that will propel improved research performance and service delivery to the campus community.
Preferred Education: MBA or related Masters and 15 years of combined experience in industry project management experience, research management, clinical trials data management, and/or an equivalent combination of education and experience. Advanced knowledge of research administration, clinical practice, and business process evaluation and analysis.
Preferred Education, Experience and Skills: MBA or related Masters and 15 years of combined experience in industry project management experience, research management, clinical trials data management, and/or an equivalent combination of education and experience. Advanced knowledge of research administration, clinical practice, and business process evaluation and analysis.
Required Skill/ability 5: Experience with industry trial management and FDA electronic clinical trials data submission. Experience preparing budgets, forecasts, financial plans, integrating multiple, complex pieces of financial information to identify themes, trends, and issues. Extensive knowledge of data standards: CDISC CDASH, SDTM, ADaM + HL7 FHIR; coding standards: MedDRA and WHODrug Global.
Posting Position Title: Sr Assoc. Director, Systems and Project Mgmt, YCCI
Required Skill/ability 3: Comprehensive and advanced communication skills. Strong written, oral presentation development and delivery. Problem solve with University and external stakeholder input in large, non-homogeneous groups. Sophistication in managing expectations, excellence in communication and track record of facilitating conversations with senior leaders; management by influence.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Sr. Assoc Dir, Systems & Project Management, YCCI
Required Skill/ability 1: Deep understanding of, reflecting work experience in, executive leadership in the academic medical practice and clinical/translational research setting including policy development and educational innovation. Capacity to manage multiple priorities, delegating appropriately and effectively to achieve organizational goals and objectives in efficient and focused manner.
Required Skill/ability 4: Extensive knowledge of federal and state regulations protecting human subjects involved in research, grants management and regulation, demonstrated by eight or more years of experience in an organization leadership position. Comprehensive technical knowledge of FDA and EMA data standards and regulations, data management and coding requirements.
Required Skill/ability 2: Strong ability to inspire change and transform organizations. Strong interpersonal skills and ability to work well and communicate effectively with external organization and funders, faculty, and staff, one-on-one and in group settings. Strong organizational and analytical skills. Strategic planning and organizational assessment/evaluation skills.
Bachelor's degree and 15 years of experience in clinical research management or an equivalent combination of education and experience.
Internal Number: 61999BR
About Yale University
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.