Exec Director Clinical Research Operations

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Executive Director for Clinical Trials Operations & Process Improvement

Duties: Instrumental to lay the groundwork in support of the expected growth and expansion of clinical research activities across Health Sciences Departments. Be a member of the Executive Committee, and other advisory groups that may be added. Responsible for clinical research administration across Health Sciences, the clinical trials contracting project management office, the clinical research billing project management office, affiliations and strategic management. Advises the AVC of Translational Medicine and coordinates with other senior campus officials on all matters of interest to the AVC. Manages confidential and sensitive issues for the AVC for Translational Medicine and develops solutions to a wide range of issues in all areas of clinical research administration involving the AVCs. Performs a wide range of duties which require tact, sensitivity, independent judgment, diplomacy, organizational skills, flexibility, and discretion. Coordinates, develops, oversees and implements clinical trials contracting and budgeting processes with all primary line officers and functional managers in the clinical research administration area. Specific key partnerships include the Director of the Office of Coverage Analysis Administration and members of the project management offices. Works in close collaboration with clinical research administration leaders including other members of the senior administration (i.e., the chief administrator and others). Responsible for integrating multiple areas of the organization on issues, and moving issues to resolution, and is paramount to the Associate Vice Chancellor’s success in managing the the clinical trials enterprise. Will have a primary influence on the ability to meet the twin goals of realizing patient revenue and complying with applicable laws. Interactive, and inclusive position that requires direct and continuous interaction with leadership of components of the Health Sciences, as well as the Campus and the University. Direct interface with the faculty PIs to ensure that appropriate communication and timely issues resolution are implemented to address their requirements. Provide leadership to coordinate and improve the clinical trials contracting and budgeting processes through the creation and leadership of a Clinical Translational Research Project Management Office. Direct interface with the faculty PIs and their research teams to ensure appropriate communication related to change management, customer relationship management, training strategy, and timely issues resolution. The goal is to provide efficient, accurate, and timely service to University investigators and clinical trials sponsors, resulting in clinical trial contracts that protect University and our investigators and staff while facilitating the start-up of industry clinical trials. Improvements will include: standardized workflows for principal investigators; -increased speed in the contracting and budgeting process to be more competitive; improved processes and work flows for IRB applications and other regulatory requirements for initiating a clinical trial; will become a more desirable place to conduct studies and increase value of research; and -budgets that are beneficial to University, the departments, and the principal investigators. After an initial process improvement effort, continued monitoring of and course correction to the clinical trials process will be necessary to ensure continued success. Development metrics and collection of data to track performance of various clinical trial processes. Provide leadership to coordinate and improve the clinical research billing process and clinical trial processes across campus, with the goal of ensuring compliance, realizing revenue in a timely manner, and increasing the efficiency of the process for principal investigators and study coordinators. After completing the initial process improvement effort, ongoing monitoring and course correction will be required to ensure that the clinical research billing effort continues to be successful in addressing all needs. Efforts will impact the $100 million clinical trials enterprise. For both the clinical trials contracting and budgeting processes, and for the clinical research billing process, it will be necessary to exert leadership across a matrix organization involving a number of different Health Sciences’ offices. Drive efficiencies and improvements in these areas by engaging in creative problem solving as well as developing and implementing innovative solutions. Respond to issues raised by faculty members and others. Triage and follow such issues to execution or resolution. Will provide high level coordination and guidance for the Health Sciences’ clinical research administration activities which includes the Office of Clinical Research Administration (Office of Clinical Trials Administration and Office of Coverage Analysis Administration), Office of Research Compliance, Clinical Research Billing, etc. Will work with the leaders of these areas to improve clinical trials research administration and related contracting functions. Leadership responsibility for the OCAA $1 million operating budget. BE in contract management and negotiation could affect millions of dollars in activity, including industry research and clinical trials agreements. Drive efficiencies and improvements for this unit’s responsibilities by engaging in creative problem solving as well as developing and implementing innovative solutions. Participate in screening applications, interviewing candidates and either make suggestions for selection decisions or recommend individuals for hire. Participate in training and assigning work to new and continuing employees. Provide guidance on performance standards and University procedures. Independently provide input on performance evaluations, including communication with clinical research administration employees as required. Make recommendations for employee incentive awards and salary increases including merits and reclassifications. Make recommendations in the determination of disciplinary actions for clinical research administration employees, with authority to recommend same to higher level management. Serves as the Associate Vice Chancellor’s and as the liaison to these affiliates. Manage affiliate relationships and negotiate affiliate agreements. Manage relationships with external units and agencies to proactively represent and advocate. Triage and follow issues to execution or resolution. Lead improvements in these areas by engaging in creative problem solving as well as developing and implementing innovative solutions. Exercise judgment and independent initiative in bringing information or issues to the Associate Vice Chancellor. Represent the Associate Vice Chancellor at University, community and other meetings. Act on behalf of the Associate Vice Chancellor. Develop procedures for implementation of programs and projects involving all units. Provide analysis of and develop innovative solutions to a wide range of problems and/or initiatives related. Lead various and myriad ad-hoc analytical studies and committees and data collection efforts that respond to requests from the Associate Vice Chancellor. Provide day-to-day and long-range assistance to the Associate Vice Chancellor on a wide range of assignments, both internal and external to the San Diego campus. Formulate and recommend corrective action to the Associate Vice Chancellor and other senior managers. Work with the Associate Vice Chancellor and other senior leaders in short- and long-range strategic planning. Responsible for the oversight and implementation of action plans related to strategic plans and initiatives. Oversee, evaluate, and execute policy implementation at the request of the Associate Vice Chancellor.

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