PROJECT LEADER I - Real World Evidence, DCRI - Real World Evidence

Durham, NC
Jul 07, 2017
Institution Type
Four-Year Institution

diversity employer

PROJECT LEADER I - Real World Evidence, DCRI - Real World Evidence

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

Occupational Summary
The Pragmatic Health Services Research (PHSR) Project Leader I position provides leadership to the department and to projects for application of information technology and health services research data management. This includes identifying research and business objectives and informatics solutions used in clinical research and health services data management operations. This can include translational research, clinical research, health services research, and health policy projects. The PHSR Project Leader I has knowledge of biomedical informatics practices including medical computing, terminology, health care and research data systems, and health information exchange, including the use of electronic health data, including claims data, in clinical and policy research. The PHSR Project Leader I oversees assigned projects and is active in developing more efficient and effective data management support for research projects supported by the department. Close collaboration with other functional areas within the department and across Duke and with external organizations is necessary. The PHSR Project Leader I typically leads operations on one or more biomedical or policy research projects of average to moderate complexity, at times with oversight of a more senior project leader. Travel is required.

Work Performed

Administrative Management
-Includes supervisory responsibility for assigning work to others, reviewing completeness and accuracy of work of others, and giving recommendations, advice, or guidance to others.

-Manages PHSR staff and supports and contributes to administrative processes for the department.

-Holds responsibility for and provides technical, fiscal, and management oversight for assigned projects and tasks. Projects may be of moderate complexity or pieces of larger projects managed by a more senior level project leader. In addition, the position is responsible for providing service-oriented support to other functional subgroups, departments, and project teams.

Project Leadership
-In addition to project management, the PHSR Project Leader I is expected to provide leadership on behalf of the project and organization to ensure the success of Duke's research endeavors.

-Work alongside faculty to develop project objectives, methodology, and operational solutions that will meet scientific and strategic goals.

-Responsible for assuring that timelines, costs, and deliverables of PHSR projects are well managed. This will often require external relationships and managing subcontracts.

-Contribute to business development activities for PHSR projects such as presentations to prospective sponsors, development of scope of work, contract assumptions, and cost estimates.

-Consult with collaborating organizations and vendors on data integration, related regulations, and implementation of project requirements.

-Participate in industry initiatives, such as technical and process standards development, professional society administration, industry-related certification programs, and conference planning and execution.

-Capture experiences and lessons learned as routine part of project lifecycle.

-Create routine mechanisms for informatics and PHSR issues to be collected and communicated to project teams.

-Manage internal and external customer expectations.

-Identify and ensure compliance with regulations and policies.

-Lead PHSR activities supporting research projects, including requirements and product evaluation, system design and customization, data structure design, technical specifications and associated documentation. Often this includes leading a cross-discipline team.

-Understand and represent the user perspective when designing technical solutions, facilitate and enhance the discussions with clinical and technical teams.

-Develop and maintain expertise in the following: electronic health records and health information organizations: CMS and other payer data structures, best practices in using and linking data sources and assessing data quality; statistical principles and considerations for clinical data management; terminology and coding dictionaries and procedures used in health care delivery and research, and understanding of emerging tools and technologies; and understanding of emerging tools and technologies; relational and/or analytical database design, programming language(s), data transfer and query methods, especially in distributed data networks.

-Focus on efficient and easily adopted methods for integrating different types of data (ie, clinical data, administrative data, payment data, biospecimens, and novel data sources) across systems or organizations.

-Perform technical support tasks: problem space analysis, writing specifications, data modeling, and programming, systems testing, and troubleshooting as needed.

-Consult on or provides direct support for complex research efforts with significant health services research components across the Duke community and collaborators.

-Identify and support the development, adoption and use of tools, templates and best practices across projects.

-Identify and produce resolution to common problems including appropriate people to ensure successful resolution and take steps to reduce potential for recurrence on this or other projects.

-Educate internal and external partners on the value, role, and methodology provided by PHSR, including use of electronic health record, payer and site and patient-reported data for use in clinical and policy research.

-Maintain working knowledge of value and best-practices biomedical informatics, electronic health records, CMS and health care payer data, patient-reported data, and health services research.

-Develop and conduct training sessions for internal and external staff on a regular basis; present at conferences and/or publish in peer-reviewed journals.

-Contribute to department training and development infrastructure.

Requisition Number


Duke Entity

Job Code

Job Family Level


Full Time / Part Time

Regular / Temporary


Minimum Qualifications


Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physicia's Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or
2. Completion of a master's degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or
4. Completion of a bachelor's degree plus a minimum of four years closely related research experience. **State of North Carolina license may be required.**


None required beyond that described above.


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

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.


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