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 Department of Surgery is seeking a Clinical Data Manager. This position will responsible for providing comprehensive operational, regulatory, data management, and scientific support for complex clinical research studies. The role supports the full research lifecycle, from study development and protocol implementation through data collection, analysis, regulatory reporting, and study closeout. It will require an individual who can independently manage complex research responsibilities, apply advanced clinical research knowledge, support high-quality data and regulatory practices, and collaborate effectively with investigators, research teams, sponsors, and institutional stakeholders.

Minimum Requirements:

• Completion of an Associates Degree
• 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.

Other Requirements:

• The Clinical Data Manager role requires experience with REDCap, SQL, and Epic Clarity and/or Caboodle to support clinical research in the Department of Surgery. Required skills include developing and maintaining REDCap databases, forms, and surveys; writing and troubleshooting SQL queries to extract and transform EHR data; and understanding Epic data structures to identify relevant clinical information. Candidates should also demonstrate strong skills in data validation, quality assurance, documentation, secure handling of sensitive data, and collaboration with investigators and study teams across multiple grant-funded studies.

Be Bold.

Position Description:

Research Operations and Regulatory Compliance

• Research agreements and regulatory documentation (MTAs, CDAs, DUAs, DTAs).
• Knowledge and application of institutional policies and regulatory requirements.
• Protocol submissions and study documentation.
• Development, implementation, and maintenance of standard operating procedures (SOPs).
• Study-level documentation for complex, procedural, and interventional studies.
• Research process coordination and workflow management.
• Facilitation and leadership of multidisciplinary research meetings.

Safety, Ethics, and Regulatory Reporting

• Preparation and submission of regulatory and safety reports.
• Sponsor and agency reporting requirements.
• Institutional research compliance.
• Application of regulatory and ethical requirements throughout the study lifecycle.

Research Data Management and Quality Assurance

• Research data collection, entry, and management.
• Development of data collection tools and SOPs.
• Electronic Data Capture (EDC) and Electronic Case Report Forms (eCRFs).
• Application of data standards (ICD-10, CDISC, MedDRA, WHODrug).
• Common Data Elements (CDEs).
• Data workflow mapping and lifecycle management.
• Data security, privacy, and vulnerability identification.
• EDC validation, testing, and 21 CFR Part 11 compliance.
• Data quality assurance, monitoring, and issue escalation.
• Data cleaning, merging, recoding, scoring, and imputation.
• Data de-identification and Safe Harbor standards.
• FAIR data principles and open science practices.
• Data sharing plans and repository submissions.

Data Analysis, Reporting, and Research Communication

• Quantitative and qualitative data analysis.
• Statistical analysis using SAS, R, and SPSS.
• Qualitative analysis using NVivo and Atlas.ti.
• Preparation of analytical datasets.
• Development of study progress reports.
• Creation of data tables and visualizations.
• Preparation of participant-facing lay summaries.
• Communication of research findings to investigators, collaborators, and stakeholders.

Scientific Research and Scholarly Contributions

• Literature searches and critical literature reviews.
• Understanding research methodology and study design.
• Development of research protocols.
• Contribution to grant and funding proposals.
• Scientific writing and publication development.
• Preparation of scientific presentations and posters.
• Authorship and dissemination of research findings.

Clinical Site and Study Management

• Site visit preparation, coordination, and participation.
• Sponsor and Contract Research Organization (CRO) communication.
• Institutional and regulatory compliance monitoring.
• Development and implementation of operational plans.
• Protocol-specific workflow and process development.
• Study closeout and document archiving.
• Study coordination across research teams and stakeholders.

Leadership, Professional Development, and Collaboration

• Training, mentoring, and oversight of research personnel.
• Leadership of multidisciplinary teams and meetings.
• Continuous professional development and certification.
• Participation in internal and external committees and workgroups.
• Organizational awareness and navigation of institutional processes.
• Adaptability, resilience, and change management.
• Advanced clinical research and therapeutic-area expertise.
• Interpersonal communication and cross-functional collaboration.
• Knowledge sharing and dissemination of research updates.

Choose Duke.

Join our award-winning team and be part of an inclusive culture that values excellence, innovation, and discovery. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, 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.

Duke Surgery is a premier academic surgical department consisting of 185 surgical faculty and 500+ employees. The clinical practice is delivered via the Duke Health Integrated Practice, in collaboration with various affiliated hospitals of the Duke University Health System.

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

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer: Duke 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, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built oncollaboration, 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 reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: DAAS@duke.edu; phone: 919-668-1267).