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CLINICAL DATA MANAGER
Job Title: CLINICAL DATA MANAGER
Job Code: 1334
FLSA: E
Job Level: 52
Revised Date: 10/13/2025
Job Family: JF 05
Occupational Summary
Participates in or lead day to day clinical research data operations conducted by principal investigator(s) at Duke Health; performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.
Work Performed
Research Operations
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
Knowledgeable in regulatory and institutional policies and processes; applies knowledge appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).
Develops or helps develop SOPs.
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.
Safety and Ethics
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Data
Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data.
Understands and is able to identify when various data standards should be used in creating electronic case report forms (ECRFs) and electronic data capture systems (EDCs), and integrates according to best practices (E.g. IDC 10, CDISC, MedDRA, and WHODrug). Demonstrates awareness of common data elements for research and understands how they would be applicable to their protocol(s).
Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols.
Maps a protocol s data workflow including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
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. Recognizes when 21 CFR Part 11 applies to a project, and under supervision may conduct some testing and documentation for Part 11 projects.
Ensures accuracy and completeness of data for all studies. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance (QA) procedures.
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.
Demonstrates and applies open science practices and the FAIR data principals. Prepares data for deposit in repositories following publication or study closeout. Locates and follows repository specific requirements to submit study data for sharing. May draft data sharing plans for clinical studies that ensure data and documentation will support re use.
Innovatively uses technology to enhance a research process.
Performs de identification on data sets (does not include redacting participant records) to Safe Harbor standards as permitted by the protocol and contracts (e.g., DTA, DUA, and CTA). May act as a federated honest broker for Protected Analytics Computing Environment (PACE).
Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.
Conducts rapid and or in depth qualitative analyses or uses statistical tools (e.g. SAS, R, SPSS) to perform statistical analysis. Codes quantitative data using statistical tools to prepare for analysis under direct supervision from Biostatistician and PI or critically examines and interprets qualitative, unstructured semi structured data, and rigorously explains findings in relation to the research context; includes the use of qualitative data analysis software (e.g., NVivo, Atlas.ti) to code and categorize the data.
Scientific Concepts
Assists with or contributes to the development of funding proposals.
Independently conducts literature searches and reviews.
Develops elements of research protocols using scientific proposals from the PI.
Demonstrates a basic understanding of the elements of research study designs.
Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.
Site and Study Management
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and contract research organizations (CROs).
Ensures that studies are conducted in compliance with institutional requirements and other policies.
Follows, and may develop or implement, operational plans (e.g. protocol specific systems and documents including process flows).
Prepares studies for closeout and document storage.
Leadership and professionalism.
May train or oversee others in the above tasks.
Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. May serve on committees and workgroups internal to Duke or externally in therapeutic area of research.
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
Demonstrates resilience and is adaptive to change.
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Required Qualifications at this Level
Education/Training
Completion of an Associate's degree
Experience
Work requires a minimum of 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. A Bachelor's degree may substitute for 2 years required experience.
Skills
Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an 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, (including pregnancy and pregnancy related conditions), sexual orientation, or military 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 essential job 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.
