Clinical Data Manager - Duke Cancer Institute

Duke Careers•Durham, NC

2d•$59,829 - $99,960•Onsite

About The Position

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.

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
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

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.
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.