RESEARCH PROGRAM LEADER, SR

Be You.

Duke University SOM offers a number of state-of-the-art shared resources that are available for use by all Duke investigators. Shared resources are housed and administered by Duke research institutes and centers, including the Department of Population Health Sciences (DPHS).The Duke PopHealth DataShare (https://populationhealth.duke.edu/research/pophealth-datashare) is a shared resource managed in DPHS. The PopHealth DataShare facilitates researcher access to an extensive, shared collection of research-ready, secure electronic health data. The PopHealth DataShare is engaged in dozens of clinical research studies including observational research using EHR, administrative claims databases, clinical registries, and device data. These data are used to address research questions in: health policy, health disparities, health services research, and related areas. The DataShare resource is run by a dedicated team of expert project managers, statisticians, and programmers that help Duke researchers access and use these data to generate new insights into health and health care. The PopHealth DataShare team provides researchers with regulatory, project management, and analytical support as needed throughout the life of the study.

Position Description:

PopHealth DataShare seeks a Sr. Research Program leader to lead the oversight of the PopHealth DataShare Research Core, including efforts to grow its portfolio of supported departments, investigators, and projects. Marketing the DataShare assets and expertise in order to sustain and expand its portfolio will be a key focus of the position. As such, the role will frequently lead communications with research groups across the Duke University School of Medicine, School of Nursing, and campus researchers as well as with partnering institutions, and sponsors, serving as primary liaison and public relations lead for the DataShare Core. Develop and coordinate wider program activities with responsibility for results in terms of costs and reporting requirements.Adapt quickly and thoughtfully to the continually changing landscape of data use for research in a way that allows continued success for the DataShare.

This role will also actively contribute to grant-funded research projects based on the candidate's skillsets, i.e., project management and oversight, statistical analysis, and/or analytical programming.

The role willdirectly manage at least 4 individuals including two senior managers and teams in operations, programming, and biostatistics. They will also serve as expert resource when discussing the PopHealth DataShare with graduate/undergraduate students, clinicians, and senior staff leadership across the SOM and Duke University.

Minimum Requirements:

Education:

Completion of a Bachelor's degree.

Experience:

Work requires a minimum of eight years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.

Preferred Skills:

• Preferred skills in at least one area: biostatistics, programming, or project management (ideally with skill in 2+ of these areas)
• Strong and effective written and verbal communication.
• Comfortable multi-tasking and prioritizing
• An ability to evaluate and pilot new concepts to better serve customer needs
• Detail-oriented
• Budget development and effort management
• IT/data security knowledge for storage of highly sensitive data/PHI
• Knowledge of Duke contracting and agreement policies

Be Bold.

Work Responsibilities:

Shared Resource Management and Development (45%):
Oversee, develop, and manage the day-to-day operations within the DataShare Research Core ensuring timely communications and adherence to regulations and guidelines. Work with department leadership to set annual core rates and fiscal year budgets; proactively review monthly financial and operational reports for variances; make adjustments as needed to ensure DataShare is operating at financial breakeven; oversee effort projections, billing and invoicing, and collection of funds. Adjust the revenue model as needed based on changes in infrastructure, demand for services, and other factors. Develop overall DataShare program milestones and timelines. Collaborate with DataShare team leaders to formulate and develop strategies for acquisition of data assets, marketing of data and staff expertise, and compliance and governance related to the use and security of secondary data sets.

Formulate and implement the short and long-range goals for the operation of clinical research and quality improvement initiatives under the PopHealth DataShare Research Core. Determine and track key indicators of DataShare success including number of awarded projects, publication rates/impact factors, and research program portfolio diversity; and establish processes for obtaining metrics through collaboration with the Department of Population Health Sciences research administration team, chief administrative director, study team members and other key DataShare stakeholders and collaborators. Monitor, report on, and evaluate DataShare effectiveness using reports generated from research administrative systems and through regular reviews. Investigate quarterly and annual trends and recommend and implement modifications to improve DataShare effectiveness in the acquisition of study funding, establishing and maintaining multidisciplinary collaborations, the acquisition of strategic data assets; and in the dissemination of high-impact research.

Related Competencies:

• Develop strategies to improve or maintain the effectiveness of the research program/shared resource.
• Engage large groups of diverse stakeholders and facilitate the development of actionable plans and measurable outcome goals.
• Establish risk, cost, time, scope, communication and quality management plans, updates with input from stakeholders, and direct staff in execution of plans.
• Provide support and leadership to large research program/shared resource provides guidance/mentorship as a subject matter expert to others who develop or manage large research programs or studies.
• Develop, negotiate, and oversee budgets, and allocate and forecast resources.
• Oversee, supervise, or mentor staff who manage the day-to-day operations.
• Provide guidance to faculty investigators, divisional or Duke office leaders on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.).
• Frequently represents research program or shared resource on behalf of the PI.
• Work with institutional leaders and offices to handle complex issues related to contracts and agreements.
• Help the research program resolve complicated contractual or infrastructure problems.
• Prepare for and provide support for monitoring or audit activities.
• Provide oversight, training, and expertise regarding data governance documentation for all studies, including those that are complex in nature.
• May provide input for institutional SOPs, Data Use Agreements, and Data Management and Sharing plans
• Prepares for and leads research program meetings.
• Ensures good communication within the research program, including mentoring staff to improve communication strategies.
  

Research Operations (25%)

In addition to fiscal, administrative, and public relations activities in support of the DataShare core, this position will support research at the project level for DataShare-engaged projects. Specific job duties are dependent on research background, but could include serving in project management, biostatistician, or analyst/programmer role in support of research projects across Duke.

Related Competencies:

• Provide significant intellectual contribution to the research program/shared resource, including substantial leadership in developing the scientific and data content of research proposals and manuscripts.
• Establish and maintain internal (Duke) and external communications to ensure successful research partnerships.
• Suggest hypotheses, research strategies, research partnerships, and research opportunities.Serve as an expert resource to multiple study teams/research program regarding regulatory and data use institutional policies and processes.
• Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio.
• Manage progress of collaborating stakeholders toward achieving project/program goals.

Leadership (15%)
Assist colleagues in identifying efficiencies, troubleshooting, and improving processes. May provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups working in the department and in conjunction with PopHealth DataShare. Encourage leadership opportunities for PopHealth DataShare staff. Lead a committee or task force. Actively seek out continuing education and professional development opportunities for self, study team members and direct reports. Independently lead scientific or programmatic presentations and publications. Train staff and multiple study teams in various work responsibilities. Employ escalation and performance plans to correct behavior and performance problems as needed. Serve as a unit-wide expert resource for issues related to professional guidelines and code of ethics. Identify potential problems and risks to the study, department, and institution in the conduct of clinical research lead by PopHealth DataShare. Oversee or maintain systems to collect study specific and institutional training requirements for study teams and direct reports. Develop solutions to proactively ensure DataShare, department, or division compliance with training requirements. Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research through the strategic acquisition of data assets utilizing data collected from underserved populations.

Related Competencies:

• Evaluates and implements the department, CRU, or division professional development and/or training programs to ensure they meet the needs of staff retention, continuous improvement, and development.
• Keeps current with research updates and advances in the scientific area, considers the impact on the broad research portfolio, and oversees necessary implementation.
• Serves in a leadership capacity with internal and external groups (e.g., speaks at events, leads institutional initiatives or committees).
• Develops and implements solutions at the institutional level to improve the research process.
• Uses expertise and acumen to influence change at the division, department, or CRU level.
• Demonstrates resilience, leadership, and actively facilitates change for research portfolio.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation across the broad research portfolio.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
• Establishes and assigns activities of other managers to accomplish goals of the broad research portfolio.

Ethical and participant safety considerations (5%)

Serve as expert resource to teams as they design studies to ensure ethical conduct. Independently develop work instructions and standard operating procedures related to safety and security of DataShare data assets. Serve as an expert resource for development and implementation of IRB protocols, DSMPs, and conflict of interest plans across multiple studies or study teams within the DataShare.

Data (5%)
Make determinations and collaborate with institutional and external stakeholders regarding complex data use agreements, material transfer agreements, governance, and contracts for the acquisition of clinical registry data, electronic medical records, biospecimens, device data, and administrative healthcare claims data.At the institutional level, assists with development of, or develops data provenance and security training sessions, guidelines, and policies.

Related Competencies:

• Predicts areas of vulnerability in data flow across the research portfolio.
• Serves as an expert resource across research portfolio regarding data capture, storage, management, quality, and preparation for analysis.
• Oversees implementation of data flow plans across the research portfolio.
• Ensures that study teams are familiar with and using data flow plan resources at Duke.
• Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement, as relevant.
• Oversee implementation of new technologies and ensure continuous evaluation of technology solutions throughout the research portfolio.

Communication and team science (5%)

Lead team meetings. Include others in decision-making and escalate issues appropriately. Communicate with sponsors, subcontractors, investigators, Duke offices, or vendors. Take action when communication has stalled. Act as an expert resource to junior clinical research staff liaising with sponsors, subcontractors, or vendors. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.

Choose Duke.

Join our award-winning team as identified by Forbes magazine as America's Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Diversity Statements:

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.