Informatics Project Leader I
Informatics Project Leader I
DCRI - Clinical Research Informatics
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.
The Informatics Project Leader I position provides leadership to the department and to 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 I typically leads the operations on one or more biomedical research projects of average to moderate complexity, at times with oversight of a more senior Informatics Project Manager.
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 projects and tasks. Projects may be of moderate complexity or pieces of larger projects managed by a higher level Project Manager. Additionally, is responsible for providing service-oriented support to other functional sub-groups, departments and project teams.
In addition to project management, the Informatics Project Manager is expected to 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 require external relationships and managing subcontracts.
Contribute to 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
Participate 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 life-cycle.
Create routine mechanisms for informatics issues to be collected and communicated on project teams.
Manage internal and external customer expectations.
Identify and ensure compliance with regulations and policies.
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 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, and programming, systems testing, and troubleshooting as needed.
Consult on or provides direct 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.
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 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.
Work requires graduation from an accredited degree program providing clinical training as a
Registered Nurse (RN), Physician'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, Radiological Technology, Licensed Practical Nurse) plus a minimum of five years healthcare experience; or
2. Completion of a masters degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or
3. Completion of a bachelors degree plus a minimum of three years directly related experience in clinical trials research; or
4. Completion of a bachelors degree plus a minimum of four years closely related research experience.
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.
1635 CLINICAL TRIALS PROJECT LEADER I
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer
committed to providing employment opportunity without regard to an
individual's race, color, religion, age, gender, sexual orientation,
national origin, genetic information, veteran status, or disability.
Work requires graduation from an accredited degree program providing
clinical training as a Registered Nurse (RN), Physicians 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 masters degree in Public Health, Health
Administration or a related area with one year directly related
clinical trials research experience; or
3. Completion of a bachelors degree plus a minimum of three
years directly related experience in clinical trials research; or
4. Completion of a bachelors 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.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
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.