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.

Be You.

The Duke Center for Human Systems Immunology is seeking a detail-oriented data analyst to fulfill a key role as Clinical Data Manager to participate in and lead laboratory data operations to assess the antibody response to vaccination in clinical trials. The main goal of this position is to execute data processing and reporting tasks and support development of reports and lab information systems.  This candidate must be very organized, possess excellent communication skills, have a high level of attention to detail, thrive in a regulatory/GCLP environment, enjoy working in a fast-paced lab environment with multiple priorities, and be able to work well as part of a team.

Minimum Requirements:

• Associate’s degree
• Two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.

Preferred Qualifications:

• Bachelor’s degree in biological science or related field
• Strong background in coding languages such as R and Python, laboratory techniques with technical precision, experience working in a GxP or regulatory environment is a plus.
• Must be able to manage multiple and rapidly changing priorities and have the ability to quickly learn new skills
• Must be detail-oriented and well organized with strong communication skills and the ability to work in a fast-paced interactive team environment.
• Knowledge of basic mathematical, data collection and research principles normally acquired through education and training.
• Proficient with Microsoft Office Suite.

 

Other Requirements:

This position is onsite with the flexibility for remote.

Be Bold.

• Independently perform programmatic data processing, transformation, and validation tasks using R, python, and other programming tools;   maintain and curate structured databases and study datasets to support ongoing laboratory and study operations across multiple assay platforms. Prepare, format and transmit datasets, reports, and supporting materials to external groups and internal collaborators, and prepare reports in support of data management operations to ensure the completion of requests made to the DAMT.  Coordinate with study managers, statistical teams, and assay teams to meet defined timelines and quality expectations.

 

• Translate assay team-defined QC requirements into executable data rules and lead execution and optimization of multi-step quality control (QC) procedures for various research functional groups, applying defined inclusion/exclusion rules, data selections, and validation checks to ensure data integrity prior to reporting or data release. Contribute substantively to the design, implementation, and continuous improvement of QC processes for new and existing assay pipelines.

 

• Maintain and standardize internal databases, data definitions, formats, and documentation across the Tomaras lab and affiliated laboratories.  Author, revise, and/or manage standard operating procedures,  data and file format dictionaries, validation materials, other process documentation.  Review external data transfer plans, and support audits, inspections, and regulatory activities through participation in code review, system qualification, and verification/validation efforts, including execution of test cases, documentation of outcomes, and ensuring audit readiness. Collaborate with other DAMT members, lab leadership, study managers, and quality assurance department to ensure alignment and compl