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.
Systems Management (~75%)
• Manage operation of various software and Laboratory Information Systems (LIS) utilized in the center and affiliate laboratories under the Department of Surgery, coordinating work conducted simultaneously to meet deadlines in adherence to applicable regulatory practices and data & application management team (DAMT) protocols.
• Develop tools to improve functionality for various software and LIS systems either programmatically utilizing various vendor APIs or through internal GUI based tools. Collaborate with functional groups to define requirements and determine specifications for requests made to the DAMT, ensuring functionality meets user needs.
• Coordinate efforts between laboratory staff, the DAMT, and IT for day to day to support of LIS systems and software. Act as liaison between DAMT, laboratory staff, and vendor relations to facilitate support, development, and other implementation of systems and software.
• Implement and improve on practices supporting the software development life cycle. Develop tools and procedures for deployment, testing, documentation that facilitate continuous integration and delivery.
• Work with various functional groups on the development, integration, and maintenance of data processing pipelines into various systems utilized by the DAMT to support research and clinical trial operations.
• Perform systems compliance duties to support clinical trial operations. Advise and participate in risk assessment, validation plan design, and qualification testing for various software’s and systems. Develop and conduct change control procedures to maintain compliance.
• Write and revise standard operating procedures, policies, reports, and other process documentation working closely with DAMT manager, study managers, and quality assurance department.
• Provide recommendations to investigators, administrators, and collaborators on appropriate tools to support laboratory operations, providing technical and financial breakdowns, and problem resolution.
• Perform other duties as assigned.
Data Management (~25%)
• Manage and coordinate large complex datasets for center and affiliate laboratories, coordinating work to be completed by deadlines and adhering to sponsor or collaborator specifications and applicable regulatory practice in conjunction with DAMT guidelines.
• Maintain databases and internal data formats to be utilized across systems.
• Oversee the development and improvement of data processes for new and existing assay platforms. Advise in the development and planning of reports and analyses to support laboratory processes. Coordinate operations between external partners and internal groups to facilitate implementation, maintenance, and support of data pipelines.
• Perform other duties as assigned.
• Perform duties autonomously under the direction of the DAMT manager, working with data technicians to delegate tasks and over the see the completion of work. Train data technicians on systems related tasks and oversee the development of their job related skill sets.
• Train laboratory staff on systems practices upon hire and in the event of systems changes. Assist with hosting laboratory workshops and information session on relevant topics. Cross train DAMT members on performed duties as needed.
• Work closely with the DAMT program manager on progress and allocation of appropriate resources for upcoming deadlines to facilitate project planning.
• Perform all other duties as assigned.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Knowledge, Skills and Abilities
Fundamental knowledge and practical ability with any of the programing languages relevant to the environment (R, Python, SQL, VBA, JS, SAS).
Awareness of any relevant regulations (21 CFR Part 11, GCLP), computer system validation practices, and software development life cycle is a plus.
Knowledge of clinical research environments is a plus
Work requires a bachelor's degree.
Work requires one to two years of clinical of either laboratory C.S., data management, I.T. experience or laboratory experience with an equivalent combination of relevant education in C.S., data management, or I.T.
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.