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.

The Duke Cancer Institute (DCI) Thoracic Clinical Research Program (THRC) is seeking an experienced Clinical Data Manager to play a critical leadership role in the planning, coordination, and execution of complex oncology clinical trials, including studies involving Investigational Products (IP). In this role, you will partner closely with Principal Investigators, study teams, sponsors, and institutional partners to ensure the integrity, quality, and compliance of clinical research data supporting cutting-edge cancer research.

You will be deeply involved in all phases of clinical trials—from study start-up through closeout—while serving as a key resource for data quality, regulatory compliance, participant safety, and research ethics. Much of your day will focus on managing clinical trial data using Electronic Data Capture (EDC) systems, identifying and resolving data discrepancies, ensuring documentation accuracy, and protecting data security and provenance.

This role offers the opportunity to combine hands-on data management with leadership, mentorship, and collaboration across multidisciplinary oncology research teams. Your work will directly support research that advances treatment options and outcomes for patients within the Duke Cancer Institute.

Minimum Requirements

• Completion of an Associate’s degree
• A minimum of two years of relevant clinical or research experience
• Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship Program may substitute for one year of required experience

Preferred Qualifications

• Bachelor’s degree
• Prior experience working in clinical research, preferably in oncology or complex clinical trials
• Experience working with Electronic Data Capture (EDC) systems
• Familiarity with clinical trial regulatory requirements, documentation standards, and research compliance

Other Requirements

• Ability to maintain required Duke University and project-specific training and certifications
• Knowledge of and adherence to institutional policies, SOPs, regulations, and protocol requirements governing clinical research
• Strong written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced research environment

This position is onsite. The work is performed on-site or at a designated Duke University assignment location.

Be Bold.

Clinical Trial Operations, Study, and Site Management

• Provide leadership and coordination for multiple complex oncology clinical trials and research studies, including those involving Investigational Products (IP), within the Thoracic Clinical Research Program.
• Partner closely with Principal Investigators (PI) and study teams to plan, initiate, implement, and successfully conduct clinical research studies from start-up through closeout.
• Lead and support participant recruitment, screening, consent, enrollment, scheduling, and study visits; conduct and document informed consent and research visits as required.
• Employ and evaluate recruitment and retention strategies, analyze recruitment and retention data, identify challenges, and recommend solutions to improve enrollment outcomes.
• Maintain compliance with institutional, regulatory, and protocol requirements, including management of regulatory binders, enrollment logs, delegation of authority logs, and participant registration in systems of record.
• Accurately document and promptly report adverse events (AEs) and ensure follow-up as required by protocol and regulations.
• Participate in site initiation, monitoring, and closeout visits; assist with the development and implementation of new clinical studies.

Data Management and Quality Oversight (Primary Focus)

• Enter and manage clinical trial data in Electronic Data Capture (EDC) systems with a high level of accuracy and attention to detail.
• Monitor data quality, identify discrepancies or missing data, investigate data issues, and collaborate with study teams to resolve inconsistencies.
• Ensure data completeness, accuracy, integrity, and timeliness in alignment with study timelines and sponsor expectations.
• Comply with institutional processes, policies, and systems related to data management, security, and provenance.
• Recognize, report, and assist in resolving vulnerabilities related to physical and electronic data security.

Communication and Collaboration

• Serve as the primary liaison between sponsors, Principal Investigators, study staff, and internal partners for assigned studies.
• Communicate clearly, professionally, and timely in response to emails, phone calls, and inquiries.
• Escalate concerns, risks, or protocol deviations appropriately and collaborate with leadership to resolve study-related challenges.

Financial and Administrative Support

• Support study financial activities, including documentation and tracking of study payments and participant care expenses.
• Monitor financial milestones and coordinate with financial teams on budget development, maintenance, and study closeout activities.
• Assist in the development of Conflict of Interest (COI) documentation, Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs).
• Support coordination with external monitoring boards as required.

Leadership and Professional Development

• Actively participate in team meetings, committees, task forces, and ad hoc working groups.
• Serve as a subject matter expert and trusted resource for colleagues and teammates.
• Mentor staff, including peers in the same job title, and support team members in completing project work effectively.
• Encourage professional growth by pursuing continuing education opportunities and participating in scientific presentations and publications as appropriate.
• Assist with coordinating educational and documentation needs for ancillary staff to support protocol compliance.

Ethics and Compliance

• Clearly communicate to staff and research participants the distinction between clinical care and research activities, including associated risks and benefits.
• Recognize when participants or staff struggle with the research–clinical distinction and work proactively to ensure understanding.
• Summarize and reinforce professional guidelines, ethical standards, and codes of conduct governing clinical research.
• Maintain compliance with all Duke policies, SOPs, regulatory requirements, and protocol-specific obligations.

Performs other related duties as assigned.

Choose Duke.

The Duke Cancer Institute is a nationally recognized leader in cancer research, clinical care, and innovation. As part of the Thoracic Clinical Research Program, you will contribute to impactful research focused on improving outcomes for patients with thoracic malignancies while collaborating with world-class clinicians, scientists, and research professionals.

Duke University offers a collaborative, mission-driven environment that values integrity, discovery, inclusion, and excellence. In addition to meaningful work that advances patient care and scientific knowledge, Duke provides a comprehensive and competitive benefits package that supports your professional and personal well-being.