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RESEARCH PROGRAM LEADER, SR
Job Title: RESEARCH PROGRAM LEADER, SR
Job Code: 1281
FLSA: E
Job Level: 69
Revised Date: 10/13/2025
Job Family: JF 05
Occupational Summary
Leads the development, implementation, and oversight of major research program(s) and shared resource(s) led by investigator(s) and faculty; Performs and oversees a variety of complex duties involved in the analysis, interpretation, and communication of data related to program and project milestones. Leads content and direction of major research program(s) and shared resources(s). Leads and reports on efforts to obtain and manage study or program funding. Frequently leads communications with other research groups or programs, serving as primary liaison and public relations lead for the research program. Develops and coordinates wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.
Work Performed
Program Management and Project Development
Develops strategies to improve or maintain the effectiveness of the research program or shared resource. Engages large groups of diverse stakeholders and facilitates the development of actionable plans and measurable outcome goals. Manages progress of collaborating stakeholders toward achieving project and program goals. Establishes risk, cost, time, scope, communication and quality management plans, updates with input from stakeholders, and directs staff in execution of plans.
Provides overall leadership of large research program or shared resource; provides guidance or mentorship as an operational subject matter expert to others who develop or manage large research programs or studies. Develops, negotiates, and oversees budgets. Allocates and forecasts resources. Oversees, supervises, or mentors staff who manage the day to day operations. Provides 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.).
Provides significant intellectual contribution to the research program or shared resource, including substantial leadership in developing the scientific content of research proposals and manuscripts. Establishes and maintains internal (Duke) and external communications to ensure successful research partnerships. Suggests hypotheses, research strategies, research partnerships, and research opportunities. Frequently represents research program or shared resource on behalf of the Principal Investigator (PI).
Research Operations
Develops, oversees adherence, and trains research portfolio team members in regulatory and institutional policies and processes, screening, recruitment, retention, study monitoring, audit visits, participant and study level documentation, study visits, standard operation procedures (SOPs), specimen management, Investigational New Drug (IND) or Investigational Device Exemption (IDE) documentation, investigational products (IP), and contracts and agreements.
Works with institutional leaders and offices to handle complex issues related to contracts and agreements. Helps the research program resolve complicated contractual problems.
Participates in or leads the development of institutional policies and guidance documents about managing IP.
Participates in or leads development of monitoring and audit training sessions or policies and guidelines for research program.
May provide input for institutional SOPs and serve as an expert resource across all study teams within the research program or shared resources for navigating regulatory compliance with international studies.
Safety and Ethics
Serves as an expert resource and is knowledgeable about resources at Duke pertaining to: developing and submitting documentation and information for Institutional Review Board (IRB) review, preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies, identifying and documenting adverse event information, and conducting, documenting, and developing consent for participants for all types of studies.
Data
Serves as an institutional resource on electronic case report forms (ECRFs), electronic data capture systems (EDCs), technologies, and software to ensure the highest quality data collection and capture. Actively encourages connections with stakeholders (e.g., statisticians) and institutional resources (e.g., ISO, IRB).
Coordinates with institutional leadership on initiatives and priority setting to ensure appropriate quality assurance (QA) processes and development of data provenance and security training sessions, guidelines, and policies.
Serves as an expert in data sharing, common data elements, data standards, FAIR data and open science principles, including advising on appropriate standards for the types of research included in their portfolio. Serves as a liaison for other resources at Duke and is knowledgeable about regulations and best practices.
Predicts areas of vulnerability in data workflows across the research portfolio. Serves as an expert resource across research portfolio with regard to data capture, storage, management, quality, and preparation for analysis. Ensures that study teams are familiar with and using data workflow resources at Duke.
Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement, as relevant. Ensures continuous evaluation of technology solutions throughout the research portfolio.
Oversees implementation of data quality processes, data workflows, and new technologies across research portfolio.
May conduct rapid or in depth qualitative analyses and summarize findings. May critically examine and interpret unstructured or semi structured data, and rigorously explain findings in relation to the research context. May instruct other analysts on how to use a variety of available tools and software to code and categorize qualitative data and lead in the development of qualitative data analysis plans that align with study objectives. May serve as an institutional expert resource for various tools, methods, and applied techniques for qualitative analyses and may mentor others on qualitative analysis as appropriate to their role.
May use statistical tools (e.g. SAS, R, SPSS) to perform statistical analysis on a variety of data formats and code data using statistical tools to prepare for analysis under direct supervision from Biostatistician and PI. May create statistical analysis plans. May serve as an institutional expert resource for various tools used for statistical analysis and mentor others on statistical analysis as appropriate to their role.
Scientific Concepts
Independently writes and edits significant sections of funding proposals and grants (including drafting of research aims, background, methods, etc.), reviews articles, synthesizes the literature, and develops manuscripts.
Provides significant contribution or leadership on multiple accepted, peer reviewed publications or conference presentations.
Uses expertise in research design to develop protocols or research proposals.
Serves as an expert resource to faculty, trainees, and staff for the development of protocols for complex investigator initiated studies and research design.
Site and Study Management
Oversees the research resources and finance processes for a broad research portfolio. Works with central offices to optimize process.
Makes feasibility recommendations and develops and oversees processes to determine participation in trials.
Works with the Clinical Research Unit (CRU) or departmental leadership to ensure that studies within the research program are conducted and closed in compliance with institutional requirements, policies, and best practices.
Oversees implementation of how teams communicate with sponsors and contract research organizations (CROs), conduct site visits, manage resources (staff, supplies, equipment), implement operational plans, and use systems and system reports to manage participants and protocols across multiple research program(s) and shared resources(s).
Leadership and Professionalism
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).
May develop and implement 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 toother managers to accomplish goals of the broad research portfolio.
Required Qualifications at this Level
Education/Training
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.
Skills
Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an 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, (including pregnancy and pregnancy related conditions), sexual orientation, or military 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.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
