CLINICAL DATA MANAGER

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.

Operations:
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Develops or helps develop SOPs. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Participates in study team meetings.

Data:
Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance. Knowledgeable about requirements for depositing data and following repository and meta-data specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing. Knowledgeable about the use of data standards for developing research databases. (E.g. IDC 10, CDISC, MedDRA, and WHODrug). Innovatively uses technology to enhance a research process. May train others. Independently performs data cleaning and management tasks such as merging multiple datasets, recoding and scoring scales, imputing data, and the creation of datasets for analysis. Under supervision, develops validation and testing scripts for EDCs for new studies. Executes testing process after the completion of a build or following any project changes or system upgrades. Follows policy related to 21 CFR Part 11 compliance, and under supervision may conduct some testing and documentation for Part 11 projects.

Leadership:
Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. Trains others to communicate effectively within teams. Facilitates resolution of issues associated with teams or communication.

Type of Research:
This position is involved with all projects awarded to the Duke Reading Center (DRC), a contract research center of the Department of Ophthalmology. By the end of 2024, DRC had almost 60 active studies that span from Phase I to III/IV clinical trials, natural history studies, and secondary research projects.    Research populations are participants in ophthalmology clinical trials, primarily. Complexity of studies can vary greatly (e.g. single/multiple ascending dose Phase I studies; large randomized clinical trials with multiple study arms & differing schedules of assessments; several retinal/ophthalmic imaging types & functional tests are involved in data collection/analysis).    This position within the Data Management & Programming department at the DRC is responsible for data quality assurance processes across all studies. S/he will serve as the Validation Team Lead for the manual validation processes of our custom-built 21 CFR Part 11-compliant Electronic Data Capture (EDC) system configurations for each project; and develop & oversee the programmatic (SAS) quality control reviews of external data transfers for all studies. This position will work under the supervision of the Clinical Data Management & Programming Manager and will fulfill a supervisory role as a mid-level manager, providing training & oversight to other staff involved in Data Management activities that help ensure data quality.

Special skills:
Base SAS programming; Adept at learning computer systems (21 CFR Part 11-compliant EDC and data transmission platforms for receiving clinical imaging data);  Able to create data validation plans appropriate for EDC database/grade form specifications.

Anticipated Pay Range

Duke University provides an annual base salary range for this position as USD $58,656.00 to USD $98,000.00. Duke University considers factors such as (but not limited to) the scope and responsibilities of the position; the candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits

Education

Completion of an Associate' s degree

Experience

Work requires a minimum of two years of relevant data experience. ABachelor's degree may substitute for 2 years required 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.