Clinical Data Manager - Duke Cancer Institute

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.

Duke Health is looking for a Clinical Data Manager to join our clinical research teams and support high-impact studies led by Duke principal investigators. In this role, you will be immersed in the day-to-day operations of clinical research, ensuring high-quality, compliant, and shareable data across a portfolio of studies-many of which are complex, procedural, or interventional in nature.

If you enjoy working independently while collaborating closely with investigators, sponsors, and study teams, this role offers the opportunity to apply your technical expertise, strengthen research operations, and contribute meaningfully to patient-centered clinical research. You'll play a critical role in transforming research data into reliable evidence that advances science and improves health outcomes.

Minimum Requirements

• Associate's degree required
• Minimum of two (2) years of relevant clinical research experience. Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship Program may substitute for one year of experience
• Demonstrated experience in clinical research data collection, entry, and quality management
• Ability to work independently and prioritize multiple studies simultaneously

Preferred Qualifications

• Self-motivated, independent thinker with strong problem-solving skills
• Knowledge of oncology terminology and oncology-focused studies
• Proficiency with Medidata Rave, InForm, Medrio, and Veeva Vault EDC systems
• Experience preparing data for monitoring visits, audits, and study closeout
• Ability to train or mentor junior research staff

Other Requirements

• Ability to work in compliance with institutional, sponsor, and regulatory requirements
• Comfortable working with electronic data systems and protected health information

Be Bold.

In this role, you will:

• Manage and oversee clinical research data operations, including data collection, entry, validation, and quality assurance for multiple studies, ensuring accuracy, completeness, and compliance with protocol requirements.
• Support study and site management activities, including preparation for monitoring visits, audits, site visits, and study closeout, while maintaining comprehensive study-level documentation.
• Apply regulatory and institutional policies related to research agreements, documentation, and SOPs; recognize when MTAs, CDAs, DUAs, DTAs, and similar agreements are needed and alert appropriate stakeholders.
• Develop and maintain data management tools, SOPs, and workflows, training or mentoring study team members in data entry, quality procedures, and compliance expectations.
• Analyze, visualize, and report study data, creating progress reports, dashboards, tables, and participant-friendly summaries to communicate results to PIs, collaborators, and other stakeholders.

Areas of Responsibility:

Operations, Study, and Site Management (20%)

• Prepare for and actively participate in site visits, monitoring activities, and audits
• Maintain regulatory and study documentation for complex clinical studies
• Communicate effectively with sponsors, CROs, investigators, and study teams
• Support protocol submissions, SOP development, and operational planning
• Assist with study closeout and long-term document storage

Data Management (70%)

• Collect and enter clinical research data across multiple studies
• Identify and escalate data quality trends and issues
• Develop and apply data lifecycle and management plans
• Support open science practices and apply FAIR data principles
• Prepare data for repository submission following publication or study closeout
• Draft or support data sharing plans that facilitate re-use and transparency
• Innovatively apply technology to improve research processes
• Create reports, visualizations, and summaries for a variety of audiences

Leadership & Professionalism (5%)

• Pursue ongoing professional development, certifications, and training
• Stay current with developments in clinical research and data management
• Serve on Duke or external committees and workgroups as applicable
• Demonstrate adaptability, resilience, and organizational awareness

Safety & Ethics (5%)

• Prepare and submit documents for regulatory, safety, and sponsor reporting
• Support compliance with ethical standards and participant protections
• Train or oversee staff in safety and regulatory processes as appropriate

Choose Duke.

At Duke Health, you'll join a collaborative research community committed to discovery, innovation, and excellence. Our clinical research teams support groundbreaking studies across therapeutic areas, including oncology, and work closely with world-class investigators to translate research into better patient care.