Clinical Data Manager

Duke Careers

. Provide comprehensive operational, regulatory, data management, and scientific support for complex clinical research studies .

Posted 11/10/2026full-timeDurham • North Carolina • United StatesJuniorMid-Level💰 $61,026 - $101,959 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing complex clinical research studies, including regulatory compliance, data management, and scientific support. Proficient in developing and implementing research protocols, data collection tools, and conducting both quantitative and qualitative analyses.

Highest-signal resume keywords

REDCap Database DevelopmentSQL Query WritingStatistical Analysis Using SASRegulatory Documentation KnowledgeData Quality Assurance

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Data ManagementData ValidationStatistical AnalysisQualitative AnalysisResearch MethodologyProtocol DevelopmentData Collection ToolsElectronic Case Report FormsRegulatory ReportingData Cleaning

Soft Skills

CollaborationCommunicationLeadershipMentoringFacilitation

Tools & Technologies

REDCapSQLEpic ClarityCaboodleSASRSPSSNVivoAtlas.tiEDC Systems

Industry Keywords

Clinical ResearchRegulatory ComplianceData SecurityMTAsCDAsDUAsDTAs21 CFR Part 11FAIR Data PrinciplesSafe Harbor Standards

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

Provide comprehensive operational, regulatory, data management, and scientific support for complex clinical research studies
Support the full research lifecycle from study development and protocol implementation through data collection, analysis, regulatory reporting, and study closeout
Prepare research agreements, regulatory documentation, protocol submissions, and study documentation
Develop, implement, and maintain standard operating procedures
Coordinate research processes and workflows and facilitate multidisciplinary research meetings
Prepare and submit regulatory and safety reports
Collect, enter, manage, validate, clean, merge, recode, score, and impute research data
Develop data collection tools, EDC systems, and electronic case report forms
Perform data quality assurance, monitoring, issue escalation, de-identification, and security assessments
Prepare analytical datasets, progress reports, data tables, visualizations, and participant-facing lay summaries
Conduct quantitative and qualitative data analysis
Perform literature searches and critical literature reviews
Develop research protocols and contribute to grant proposals, scientific writing, publications, presentations, and posters
Prepare for, coordinate, and participate in site visits
Communicate with sponsors and Contract Research Organizations
Monitor institutional and regulatory compliance
Develop and implement operational plans and protocol-specific workflows
Coordinate study closeout, document archiving, research teams, and stakeholders
Train, mentor, and oversee research personnel
Lead multidisciplinary teams and meetings
Participate in committees and workgroups and share research updates

Requirements

What you’ll need

Completion of an Associates Degree
Minimum of two years of relevant research experience
Experience with REDCap, SQL, and Epic Clarity and/or Caboodle
Ability to develop and maintain REDCap databases, forms, and surveys
Ability to write and troubleshoot SQL queries to extract and transform EHR data
Understanding of Epic data structures to identify relevant clinical information
Skills in data validation, quality assurance, documentation, and secure handling of sensitive data
Knowledge of research agreements and regulatory documentation, including MTAs, CDAs, DUAs, and DTAs
Knowledge and application of institutional policies and regulatory requirements
Experience or knowledge of EDC, eCRFs, ICD-10, CDISC, MedDRA, WHODrug, CDEs, 21 CFR Part 11, FAIR data principles, and Safe Harbor standards
Statistical analysis skills using SAS, R, and SPSS
Qualitative analysis skills using NVivo and Atlas.ti
Understanding of research methodology and study design
Advanced clinical research and therapeutic-area expertise
Ability to collaborate with investigators, research teams, sponsors, and institutional stakeholders

Benefits

Comp & perks

Health insurance plans
Medical and dental care programs
Generous paid time off
Retirement programs with employer contributions
Tuition assistance for employees and their children
Family-friendly and cultural programs
Competitive benefits package