Clinical Data Manager

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 compliance.

• Independently develop and perform maintenance, testing, and validation of code and data logic workflows deployed on  Lab Information Systems (LIS) to support data processing, QC pipelines, supporting accurate representation of raw data and reliable study outputs. Support the configuration, use, and ongoing improvement of LIS and related tools by performing system development, user training,  advanced troubleshooting for laboratory and DAMT staff, and working with vendors to resolve issues and plan system updates.

• Perform witness QC activities in the electronic notebook system across multiple assay platforms, including error tracking, issue documentation, and resolution follow-up with lab staff.  Assist with electronic notebook template management as needed.

• Develop new and refine existing data processes, reporting standards, and automation efforts for new and existing assay platforms. Advise in the development and planning of reports and analyses to support laboratory processes, helping to reduce manual effort and improve consistency and turnaround time. Coordinate operations between external partners and internal groups to facilitate implementation, maintenance, and support of data pipelines.

• Develop, maintain, and enhance dashboards to monitor ticket status in terms of progress, completeness and workflow performance; provide weekly, structured updates to laboratory managers and study teams.  Prepare and present work progress updates at laboratory meetings, clearly communicating technical status, development projects, and next steps.

Choose Duke.

Join our award-winning team and be part of an inclusive culture that is committed to providing outstanding patient care, training tomorrow’s leaders, and conducting innovative research. You'll also benefit from Duke's competitive benefits package, including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Screening of Applications: Screening continues until the position is filled.