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CLINICAL DATA MANAGER, SR.
Job Title: CLINICAL DATA MANAGER, SR.
Job Code: 1335
FLSA: E
Job Level: 53
Revised Date: 10/13/2025
Job Family: JF 05
Occupational Summary
Leads day to day operations of multiple study teams managing clinical research data at Duke Health; performs a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data; lead others in navigating the clinical research environment. Collaborates with other data-focused departmental and institutional groups. Oversees the work of clinical research data and other research staff.
Work Performed
Research Operations
For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution.
Serves as an expert resource to multiple study teams for regulatory, institutional policies and processes, and study-level documentation.
Maintains study-level documentation (e.g., involving datasets from multiple sources, big data, or non-standardized data) for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
Develops, oversees adherence, and trains multiple study teams in the use and development of standard operating procedures (SOPs).
Leads effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
Safety and Ethics
Provides oversight and training to multiple study teams who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
Data
For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs electronic case report forms (ECRFs) and electronic data capture systems (EDCs) to collect data according to protocol. Provides training and oversight into EDC creation using appropriate data standards and common data elements.
Oversees the process of quality assurance (QA), data corrections, and queries used by multiple study teams, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain study teams. Serves as a data corrections, queries, and QA expert resource within the Clinical Research Unit (CRU), department, or division; including liaising with and being knowledgeable about other related resources at Duke.
Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and provenance.
Oversees the process of depositing data in repositories. Provides guidance on the selection of the appropriate repository, data governance requirements, and FAIR data and open science principles.
For multiple study teams, provide guidance on the use of data standards and common data elements. Provides training and oversight into EDC creation using appropriate data standards and common data elements. For studies reporting to the Food and Drug Administration (FDA), coordinate the CDISC and CDASH data standard setup and the CDISC dataset transformation tasks.
Serves as an expert resource to multiple study teams with regard to mapping data workflow. Predicts areas of vulnerability in the data workflow plan. Determines areas where data provenance may be compromised, and helps study teams work through solutions. Ensures that study teams are familiar with data workflow resources at Duke.
Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams, as relevant.
Independently performs data cleaning and management tasks for complex protocols (e.g., involving datasets from multiple sources, big data, or non-standardized data), such as merging multiple datasets, recoding and scoring scales, imputing data, and the creation of datasets for analysis. Provides oversight and training and lends expertise to multiple study teams.
Performs de-identification on allowable data to Safe Harbor standards, or on consented data that will leave Duke under appropriate transfer agreements. Could serve as a Federated Honest Broker and may provide training to others.
Develops, oversees adherence, and trains multiple study teams on reporting results to patients and providers. Provides guidance based on CRU and institutional best practices.
Benchmarks awareness of appropriate methods for monitoring study progress based on trial design.
Recognizes when 21 CFR Part 11 applies to a project and follows policy related to testing and validation. Provides oversight and training to multiple study teams on validation and testing for EDC systems.
Conducts rapid and in depth qualitative analyses or uses statistical tools (e.g. SAS, R, SPSS) to perform statistical analysis on a variety of data formats. Codes quantitative data using statistical tools to prepare for analysis under direct supervision from Biostatistician and Principal Investigator (PI) or critically examine, interpret, and summarize findings for unstructured and semi-structured data, and rigorously explain findings in relation to the research context; Includes the use of qualitative data analysis software (e.g., NVivo, Atlas.ti) to code and categorize data.
Assists in developing a qualitative data analysis plan that aligns with study objectives and provides mentorship or education to others on qualitative data analysis tools. Provides mentorship or education to others on statistical tools for data cleaning and analysis for quantitative data.
Scientific Concepts
Independently develops substantial portions of funding proposals and grants and provides to PI for final approval. Assesses and determines solutions for operational shortcomings of proposals.
Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams.
Uses expertise in research design to provide significant contribution to protocols or research proposals.
Independently conducts literature searches or reviews and provides significant contribution or leadership on accepted, peer reviewed publications or conference presentations.
Site and Study Management
Mentors, trains, and oversees activities related to how teams communicate with sponsors and contract research organizations (CROs).
For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.
Oversees activities related to site visits and the implementation of operational plans across multiple study teams or sites.
Develops and implements closeout procedures for multiple studies across multiple teams.
Leadership and professionalism
Encourages staff to take part in professional development opportunities and provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.).
Plays a key role on committees and workgroups.
Demonstrates interpersonal skills to get work done efficiently.
Recognizes and escalates organizational issues that could be optimized to improve research process.
Actively facilitates and leads multiple study teams adoption of change in their working environment.
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 and facilitates resolution of issues associated with teams or communication.
Required Qualifications at this Level
Education/Training
Completion of an Associate's degree
Experience
Work requires a minimum of six years of research 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.
