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.

CLINICAL DATA MANAGER

100% IN-PERSON POSITION

Duke Job description

Duke University Job Descriptions | Duke Human Resources

 

Lab job description:

Summary of responsibilities:

Perform a variety of duties involved in the compilation, documentation, reporting, and analysis of clinical research data. Work with the principal investigator, scientific laboratory managers, statistical, and data management teams to compile clinical datasets for analysis of humoral immune responses induced by vaccination or infection for globally relevant infectious diseases.   

Assist the scientific laboratory managers and data management team to develop new data transformation and processing pipelines, in order to streamline project workflows and meet critical project milestones for key stakeholders.

Work performed:

Data processing and reporting

Work with statistical and research teams to coordinate data processing, QC, analysis, and transmission to external groups as necessary to ensure accurate and timely reporting of data. Create reports as needed to determine progress, adverse trends, and appropriate recommendations or conclusions as needed.

Responsible for automating assay data transformation and processing pipelines.

Establish assay data reporting pipelines for high throughput clinical trials data.

Work on optimizing existing code repositories using version control; and automizing data processing and curation codes for various data types and assay platforms.

Perform data management and processing for clinical trials datasets for local, national, and international research and industry collaborators.

Perform data management and coordination of large complex datasets for CHSI, coordinating work to be completed by deadlines and adhering to sponsor or collaborator specifications and applicable regulatory practice in conjunction with lab data policy.

Work with scientific project managers to develop automated processing pipelines for routine data management, transformation, processing and visualization activities. Share knowledge and processing codes with other members of the data management and laboratory teams for efficiency and standardization of data processing and selection methods.

Quality Control and Good Clinical Laboratory Practice/Good Data Practice

Perform quality control (QC) tasks for various research functional groups as a part of a multi-step data processing and approval process before reporting results. Work with lab staff to resolve and update QC processes and files as needed.

Lead the development and improvement of QC processes for new assay pipelines.

Scientific Concepts

Work with managers to contribute to development of figures and manuscript writing for high visibility clinical trial and research datasets.

General Duties

Maintain databases and curate internal data definitions and formats to be utilized across centers and affiliate laboratories.

Manage requirements across programs for interfacing internal and external data formats.

Maintain DAMT knowledge repository, ensuring practices and procedures are kept up to date. Write and revise standard operating procedures, data transfer plans, data and file format dictionaries, and other process documentation working closely with data team manager, study managers, and quality assurance department.

Provide detailed written weekly updates from the team, to co-ordinate the work done with team and study managers. Work closely with team manager on progress and allocation of appropriate resources for upcoming deadlines.

 

Preferred skill sets:

• Excellent written and spoken communication skills
• Ability to translate concepts and work collaboratively with cross-functional teams with differing subject matter expertise
• Proficiency in programming language (R, Python preferred, or knowledge of another programming language with desire to learn R or Python)

 

 

 

Minimum Qualifications

 

Education

Completion of an Associate's degree

 

Experience

Work requires a minimum of two years of relevant data experience. A Bachelor'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.