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.

Occupational Summary:

Participates in or lead day to day clinical research data operations conducted by principal investigator(s) at Duke Health; performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Work Performed:

Research Operations:

• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).

• Develops or helps develop SOPs.

• Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).

• Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

• Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.

Safety and Ethics:

• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

Data:

• Under direct supervision from a Biostatistician and PI, may perform basic analyses and structured data.

• Enters and collects data, and develops data entry or collection SOPs or tools. May provide training to study team members collecting or entering data.

• Manages and cleans data in preparation for analysis under supervision. Ensures accuracy and completeness of data for all studies. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures.

• Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review research data security plans (RDSPs) for multiple study protocols.

• Prepares data for deposit in repositories following publication or study closeout.

• Identifies when various data standards should be used in creating eCRFs and EDCs and integrates as necessary.

• Under supervision, performs de-identification on allowable data to Safe Harbor standards.

• Maps a protocols data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).

• Innovatively uses technology to enhance a research process.

• Prepares tables, data visualizations, and lay summaries to communicate study results with participants.

• Develops reports on study progress for the PI and other study team members and collaborators. May create clear visualizations to help communicate key information to stakeholders.

• Under supervision, develops validation and testing scripts for Electronic Data Collection Systems (EDCs) for new studies. Executes testing process after the completion of a build, or following any project changes or system upgrades. Recognizes when 21 CFR Part 11 applies to a project, and under supervision may conduct some testing and documentation.

Scientific Concepts:

• Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. Demonstrates a basic understanding of the elements of research study designs. Using scientific proposals from the PI, develops elements of research protocols.

• Demonstrates and applies basic understanding of the elements of research study designs and open science practices and the FAIR data principals Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.

Site and Study Management:

• Ensures that studies are conducted in compliance with institutional requirements and other policies.

• Follows, and may develop or implement, protocol specific systems and documents including process flows.

• Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or contract research organizations (CROs).

• Prepares studies for closeout and document storage.

Leadership and professionalism:

• May train or oversee others in the above tasks.

• Proactively seeks opportunities to add relevant skills and certifications to own portfolio.

• Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.

• May disseminate information to others.

• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.

• Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

• May serve on committees and workgroups internal to Duke or externally in therapeutic area of research.

• Demonstrates resilience and is adaptive to change.

• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Minimum Qualifications:

• Education/Training: Requires an Associate's degree

• Experience: Work requires a minimum of two years of relevant data experience. A Bachelor's degree may substitute for 2 years required experience.

• Skills: Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

• Preferences: Clinical experience preferred. Radiology experience preferred.

Job Code: 00001334 CLINICAL DATA MANAGER
Job Level: 52

Duke is an Affirmative Action/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, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Ourcollective 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 DukeUniversity and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.