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 Preformed

Operations, Study and Site Management – 10% Effort

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Develops or helps develop SOPs. May train or oversee others. Participates in study team meetings.

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. Prepares studies for closeout and document storage. May train or oversee others.

Data – 80% Effort

Under direct supervision from Biostatistician and PI may perform basic analyses on structured data. Enters and collects data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Manage and clean data in preparation for analysis under supervision. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. 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 data lifecycle and management plans 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 according to best practices. Under supervision, performs de-identification on allowable data to Safe Harbor standards. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Innovatively uses technology to enhance a research process. May train others. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders. Under supervision, develops validation and testing scripts for EDCs for new studies. Executes testing process after the completion of a build, or following any project changes or system upgrades. Follows policy related to 21 CFR Part 11 compliance, and under supervision may conduct some testing and documentation for Part 11 projects.

Leadership & Professionalism – 5% Effort

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. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Safety & Ethics – 5% Effort

Under supervision may collect information about AEs, identified in the protocol or investigator brochure. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Know and follow policies, standard operating procedures (SOPs), regulations and protocol requirements that govern clinical research.  Maintain Duke and project specific training and certification requirements.

And other work as assigned. 

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.  Employees may be directed to perform job-related tasks other than those specifically presented in this description.The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. 

Minimum Qualifications

Education/Training

Completion of an Associate’s degree.

Experience

Work requires a minimum of two years of relevant data experience. A Bachelor’s degree may substitute for two years required experience.  

Job Code: 00001334 CLINICAL DATA MANAGER
Job Level: 52

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