Senior Administrative Director, Clinical Trials Office

Department: MED-Cancer Center
Salary/Grade: EXS/13

Target hiring range for this position will be between be Range: $123,492.00 - $173,661.00 Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Job Summary:

This senior administrative leadership position provides definitive administrative oversight of the Cancer Center Clinical Trials Office (CTO) across the entire Northwestern Medicine network and all its National Cancer Trial Network (NCTN) and NU-Initiated Clinical Trials affiliates, including responsibility for Regulatory, Data Management, Quality Assurance, Multisite Coordination, and Research Oversight Committees. This person will be responsible for people management (direct reports including upper level management), cross-functional management, executive-level collaboration, strategy, vendor relationships, compliance, and budgets/resources. Provides expertise for all aspects of oncology clinical research operations, including program strategy, sponsor/vendor oversight, budget management, protocol development, and providing strategic and tactical guidance in the planning, execution, and reporting of all operational aspects of the clinical trials across multiple campuses within the NM system. The Senior Director is responsible for achieving strategic research goals, cultivating a collaborative and comprehensive research compliance infrastructure, and promoting integrity and compliance with applicable federal and state laws and research regulations, professional and ethical standards, and institutional policies and procedures throughout the research enterprise.

Provides administrative oversight at various levels of the following committees: Protocol Review Committee (PRC), Data and Safety Monitoring Board (DSMB), Quality Assurance Review Committee (QARC), Lurie Translational Resource Allocation Committee (LTRAC), and clinical research operations at affiliate sites as needed for CC Research Administration. Works collaboratively with operational leaders of the CC Finance, IT and other Medical School and Hospital units and departments engaged in clinical research.

Specific Responsibilities:

Cancer Center Clinical Trials Office:

• Under the leadership of the CC Deputy Director to provide the strategic direction for the CTO.
• Oversees and provides leadership to Regulatory and Compliance team; Central Region Clinical Trials Operations team; Network (including North, West, and all outside affiliates) Clinical Trials Operations team totaling 120+ FTEs
• Focuses on CTO process improvements based on interactions between various departments and manages high-level relationships with Program Directors, Associate Directors Administration, as well as Medical School and Hospital Departments engaged in cancer clinical research involving the CTO
• Provides oversight for the development of policies, procedures and training for the oncology research program.
• Structures the clinical trial operations organization, establishes goals and monitors performance objectives for optimal service delivery and efficient operations.
• Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion
• Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct
• Work collaboratively with Medical Network and Health System department leaders to maximize clinical trials performance, minimize risk, and assist Cancer Center in achieving its goals; Provide direction and leadership to new implementations and process improvements.
• Manages the relationships with other external institutions and organizations - reviewing metrics, gleaning better practices from peer cancer centers and assisting with the development of new network affiliations and partnerships related to clinical trials.
• Provides direct supervision of CTO Multisite Managers as these positions develop.
• Effectively lead the management of CROs/external vendors, considering appropriate and metrics, through both hands-on oversight as well as through delegating tasks internally.
• Provide critical operational input into study protocol design, oversee maintenance of trial documentation and master file, data validation and completion guidelines.
• Overall responsibility/oversight for implementing and executing operational input into clinical development plans.
• Implement and incorporate performance metrics into development planning to ensure optimal operational strategies.
• Understand and assure compliance with all NCI CCSG guidelines and mandates related to the conduct of cancer clinical research in the CTO. Oversee completion of CCSG non-competing and competitive renewal applications pertaining to all sections that involve the CTO (Clinical Protocol and Data Management, Clinical Protocol Data Management, Data Safety and Monitoring, Protocol Review and Monitoring System)
• Works in collaboration with the CC Chief Informatics Officer to provide input to support the strategic IT needs of the CTO.
• Responsible for developing CTMS updates and Plan to dynamically track workload, financial, and resource capacity.
• Represents CTO interests in clinical research infrastructure initiatives partnering with appropriate colleagues in hospital, medical school, medical group practice and University.
• Under the leadership of the Associate Director of Administration to provide high quality, efficient and cost-effective financial and administrative direction for the CTO and the overall cancer clinical research enterprise.
• Demonstrates knowledge and responsibility for processes related to CTO budgeting, cost containment, and strategic planning, and process improvement
• Develops and monitors budgets for the clinical trials operational area.
• Models and advocates for incorporation of lean thinking in every day work across the CTO. Partners with Director of Finance to optimize CTO charge capture.
• Ensures frequent and optimal collaboration with Department users of the CTO (Internal Medicine, Radiation Oncology, Pediatrics, etc.)

Cancer Center Leadership:

• Under the leadership of the Deputy Director and Associate Director for Clinical Research and with support from the Associate Director of Administration to provide leadership, planning and project management associated with operational changes for clinical research that contribute to the overall strategy, direction and vision set forth by the Cancer Center Clinical Research Oversight Committee;
• Establish, monitor and report on performance metrics of operational effectiveness, program objectives, customer service and financial outcomes. Metrics to include turnaround time for trial activation, timely and complete collection of CTO finances, employee engagement, CTO user satisfaction, # of protocol deviations attributable to CTO staff.
• Empowered to implement decisions regarding projects, programs and initiatives that support these objectives.
• Drive innovation into the Clinical Operations function and advance the CC systems and processes.
• Develop and manage effective working relationships with Investigators and other key clinical opinion leaders
• Remains current with therapeutic areas under study, industry practices / trends and FDA requirements. Applies this knowledge to current programs.
• Partners with and maintains regular contact with key stakeholders including Regulatory, Clinical Development, Legal, Finance, and others as necessary
• Works collaboratively with other NU entities as appropriate (NUCATS, IRBMed, University Office of Research, Northwestern research pharmacy) to represent the Cancer Center's interests and foster opportunities for change and improvement in the clinical research infrastructure. Demonstrating in-depth knowledge of University and National Cancer Institute policies, procedures and objectives
• Maintains a close partnership with University research functions and participates in relevant policy-making, strategic planning and consultative forums with FSM Dean's office.
• Builds relationships that foster opportunities to expand cancer clinical research portfolio.
• Oversees the collection, synthesis and communication of relevant external information from sponsors and partners that informs the Cancer Center strategy across all functions.
• Organizes information from a variety of sources to establish data banks for use in planning. Benchmarks with peer cancer centers on key processes related to conduct of clinical research. Coordinates with all levels of management (within and outside of the institution) to analyze, summarize, and prepare recommendations regarding financial plans, future requirements, operating budgets and forecasts and similar matters.
• Work with Associate Director of Administration and key stakeholders to develop an effective, efficient infrastructure to support the conduct of therapeutic clinical research at NM satellites. Meet with key leaders at satellite locations to ensure proper staffing, resources, monitoring and accountability needed to meet NIH guidelines for Good Clinical Practice
• Leads identification and development of high-performing staff.
• Management duties include interviewing, selecting and training of CTO supervisors (direct reports); setting and adjusting their rates of pay and hours of work; planning and directing their work for optimal performance and employee engagement; Management responsibilities include the authority to hire, fire, or promote assigned employees and/or make recommendations for work redesign as appropriate to ensure an optimal operation.

Miscellaneous

Performed other duties

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• Master's degree in business, health care, or equivalent
• Certification in clinical research required (regulatory, coordinator, QA, or equivalent)
• >10 years in clinical trials management required
• >20 years' experience in clinical trials conduct at NCI-designated cancer center
• Experience managing >100 staff required
• Experience managing in matrixed cancer center required (University and Healthcare system separate organizations)
• Experience in leading a successful Cancer Center Support Grant (CCSG) renewal for CTO section(s)
• Demonstrated experience in Research Financials associated with indirect costs, effort certifications, A21 guidelines, variable payment schedules and cost accounting principles.
• Experience with research IT associated with clinical trial management systems including electronic data capture, application life cycle development, data standards and system integrations.
• Experience managing in NCCN member institution
• Experience in managing a LAPS institution
• Experience managing in NCI Comprehensive Cancer Center with many locations in community settings

Minimum Competencies: (Skills, knowledge, and abilities.)

• Communication: Excellent communication skills, keeping others informed, and balancing talking and listening
• Quality: Track record of continuous process improvement and quality control, identifies and leads process improvement projects as needed
• Patient Experience: Mindset of putting patients first, striving for high patient satisfaction, and engages the patients when appropriate and necessary
• Staff Engagement: Staff engagement is a clear priority, with clear expectations set, ongoing progress review, regular feedback and guidance, and holding staff accountable
• Leadership: Role model for other leaders, helpful, respectful, transparent, approachable and team oriented, work on building relationships with colleagues and supports and creates positive working environment
• Time Management: Good time manager, plans ahead, cost conscious, thinks of better ways to do things, takes ownership, follows through, and is doing what is needed without being asked
• Coachability: Willing to learn, self-reflective, receptive to feedback, embraces lifelong learning and improvement
• Clinical Trials: is able to run any cancer trial in any cancer type, can interact with all types of cancer trials sponsors, has experience preparing for successful audits, knows how to support compassionate use and expanded access protocols
• Oncology Faculty: understands the epidemiology and etiology of common cancer types, can interact with various MDs and their extenders, can partner with faculty to achieve goals
• Healthcare System: can work with clinical operational leadership in the inpatient and outpatient setting, supports the annual goals set forth by the health system, and engages in quality projects

Preferred Qualifications: (Education and experience)

• PhD degree in public health, business, health care, or equivalent
• Serving on national committees
• Leading/serving on institutional committees and panels/taskforces
• Podium presentations on local, regional, and national level
• Relevant publications

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

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Professional Growth & Development:
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