CLINICAL TRIALS PROJECT LEADER III, DCRI TDS
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
The Data Solutions Project Leader III position provides operational leadership to the department and projects for application of information technology to the discipline of clinical research data management. This includes identifying research and business objectives and informatics solutions utilized in clinical research data management operations. This can include translational or clinical research projects. The work also includes identification and implementation of appropriate standards as well as standards development. The Data Solutions Project Leader has knowledge of biomedical informatics practices including medical computing, terminology, healthcare and research data systems and health information exchange. The Data Solutions Project Leader 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 department and across Duke, and external organizations is necessary.
The Data Solutions Project Leader III is typically the senior operational leader on one or more large complex biomedical research projects.
The Data Solutions Project Leader serves in preceptor capacity for other informatics staff.
Travel is required.
- Includes supervisory responsibility for assigning work to others, reviewing completeness & accuracy of work of others, giving recommendations, advice, or guidance to others, completes performance evaluations for direct reports, and making personnel decisions (including promotion, hiring & disciplinary actions).
- Manages informatics staff, supports and contributes to the administrative processes for the Informatics group and overall department.
- Holds responsibility for and provides technical, fiscal, and management oversight for strategically and technically complicated projects and for providing service-oriented support to other functional sub-groups, departments and organizations.
- Provide leadership on behalf of the project and organization to ensure 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 informatics projects are well managed, often requiring strategic development of external relationships and independently managing multiple subcontracts.
- Responsible for business development activities for informatics projects such as writing grants and proposals, giving presentations to prospective sponsors, scope of work, contract assumptions and cost estimates.
- Take leadership role in industry initiatives; i.e. technical and process standards development, professional society administration, certification programs and conference planning and delivery.
- Capture experiences and lessons learned as routine part of project lifecycle.
- Is able to research, apply and communicate regulatory and policy requirements for projects
- Negotiates methods to maintain budget and scope for projects; tracks resources and budgets for cross functional and external resources; Understands what are allowable expenses for various types of awards.
- Lead informatics 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/cross organization team.
- Develop and maintain expertise in the following:
- Relational database design, programming language(s), XML, data transfer methods, HL7, DICOM and CDISC standards
- Electronic Health Records and health information related organizations;
- Statistical principles and considerations for clinical data management;
- Terminology and coding dictionaries and procedures used in healthcare and research; and understanding of emerging tools and technologies.
- Focus on efficient and easily adopted methods for integrating different types of data (i.e. clinical data, administrative data, imaging, and novel data sources) across systems or organizations ensuring semantics are maintained.
- Perform technical support tasks: problem space analysis, writing specifications, data modeling, and programming, systems testing, and troubleshooting as needed.
- Support for complex research efforts with significant informatics components across the Duke community and collaborators.
- Identify and support the development, adoption and use of tools, templates and best practices across projects.
- Able to anticipate, identify and provide resolution to complex problems across multiple projects or research programs. Identify and work with the appropriate groups internal and/or external to Duke in addressing problems prior to impacting objectives and provide solutions that can be applied across projects and groups. Proactively create processes and methods for reducing problems and identify how the problem and resolution impacts costs, time and resources across groups or projects. Provides leadership and mentors others on problem solving.
- Educate internal and external partners on the value, role and methodology provided by biomedical informatics.
- Maintain working knowledge of biomedical informatics
- 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 including identification of training needs, ensure that training reflects local and industry standards.
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four 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 Associate's degree in Clinical Trials Research related curriculum plus a minimum of seven years healthcare experience; or
2. Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinicaltrials research experience; or
3. Completion of a Bachelor's degree plus a minimum of five years directly related experience in clinical trials research; or
4. Completion of a Bachelor's degree plus a minimum of six years closely related research experience.
**State of North Carolina license may be required.**
None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.