Clinical Data Management Programmer I

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

FULLY GRANT FUNDED

Duke Reading Center

Initial training may be On-Site

POSITION DESCRIPTION

The Clinical Data Management (CDM) Programmer I works under the supervision of the Clinical Data and Programming Manager (CDPM). He or she performs data management & programming tasks, including but not limited to: planning & developing programs to validate and/or support Data Management processes for data collection, integration, & quality reviews; conducting database development and/or validation activities; preparing study files & data management documentation for data cleaning activities. The CDM Programmer I may assist with other DRC directives as needed.

SPECIFIC RESPONSIBILITIES

• Assist the CDPM in working with sponsors & CROs to determine ongoing needs around clinical data management and study data integration. Serve as a backup DM contact to internal & third-party study teams for conducting data transfers via MFT/SFTP, eTMF, cloud storage, proprietary platforms, etc.
• Perform quality control activities of study data transfers, reports, tables, and other project deliverables. Develop, modify, and maintain computer programs for data cleaning processes, and collaborate with Project Management & Grading personnel to resolve any queries. Document DM processes to support best practices in clinical data management and research GCPs.
• Develop, modify, and maintain study configurations in the Reading Center electronic grading system (EGS) under the guidance of the CDPM; use custom tools to build study code, and program custom validation & display rules based on grade form requirements.
• Perform computer script validation using common data management tools such as SAS, Python, and R; develop, modify, and maintain QC programs to validate the implementation of study data importing, cleaning, merging, reshaping, coding, summarizing, and transferring.
• Develop, modify, and maintain programs that produce study deliverables of lower complexity.
• Test and debug EGS configurations to verify their accuracy, functionality, and completeness as part of the Validation Team. Communicate with other DRC department staff regarding validation statuses, grade form features & other summary information. Assist with computer system validation efforts as needed.
• Assist with the development of study DM documents & specifications for data-processing systems to include system narratives, data elements, data gathering and verification techniques & methods, input-output requirements, etc. (e.g. data transfer agreements, database design specifications, DM plans).
• Provide data reporting or visualizations to internal & external teams, as needed, to aid with study operations & monitoring. Assist with data reconciliation activities for routine and ad hoc transfers.
• Attend weekly Reading Center Data Team meetings, staff meetings, and other regular meetings around data management and research projects as they are established.

Perform other related duties incidental to the work described herein. 

DEPARTMENTAL PREFERENCES

Bachelor’s degree in computer-related field, or equivalent coursework & technical training (one year of Data Management experience, one year of progressive programming experience.).       

MINIMUM QUALIFICATIONS

Education

Work requires a Bachelor degree in mathematics or computer-related field, or equivalent coursework or technical training.

Experience

Work requiresone year of programming or analytical experience with knowledge of several computer languages, programs or systems.

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.