Informatics Project Leader II
Clinical Research Informatics
Duke Clinical Research Institute
The Informatics Project Leader II position provides 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 Informatics Project Leader has knowledge of biomedical informatics practices including medical computing, terminology, healthcare and research data systems and health information exchange. The Informatics 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 Informatics Project Leader II is typically the senior operational leader on one or more biomedical research projects of moderate complexity.
The Informatics 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 assigned, often complicated projects. Additionally, responsible 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. This will often depend on development of external relationships and independently managing multiple subcontracts.
Responsible for business development activities for informatics 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
Take leadership role in industry initiatives; i.e. technical and process standards development, professional society administration, industry related certification programs and conference planning and delivery.
Capture experiences and lessons learned as routine part of project lifecycle.
Identify and ensure compliance with regulations and policies.
Design and maintain project plans for outlining methodology and operations for complex projects.
Manage internal and external customer expectations. Renegotiate scope of work with internal and external groups.
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.
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:
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.
Perform technical support tasks: problem space analysis, writing specifications, data modeling, programming, systems testing, and troubleshooting as needed.
Support 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 projects. Identify and work with the appropriate groups internal and/or external to Duke in addressing problems prior to impacting objectives or requiring escalation. Proactively create processes and methods for reducing problems and identify how the problem and resolution impact costs.
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 three years of healthcare experience; or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiological Technology, Licensed Practical Nurse) plus a minimum of six years healthcare experience; or
2. Completion of a masters degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or
3. Completion of a bachelors degree plus a minimum of four years directly related experience in clinical trials research; or
4. Completion of a bachelors degree plus a minimum of five years closely related research experience.
None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Registration, Certification or Licensure:
State of North Carolina license may be required.
About Duke Clinical Research Institute
Duke Clinical Research Institute