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.
Occupational Summary
This position will be responsible for Advarra EDC Platform building for Duke-led Investigator Initiated Trials (iiTs) including Multisite iiTs (miiTs), validation of new Advarra EDC releases and updates and be the Data Quality and Accuracy Oversight Manager for all iiTs, including miiTs, monitoring incoming data from Duke and external sites for quality, timeliness and occasionally accuracy.
This position will be responsible for creating training and SOPs specific to good clinical data practices and data quality management for the entire CRU.
This position will be responsible for overall study and site management for miiTs that fall under Multisite Trials Service Center’s (MiSTiC) portfolio.
Work Performed
Data – 45% Effort
Provide support for various tools used for analysis and data management. Selects and implements data capture methods appropriate for the research program.
Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes. Manage and clean data in preparation for analysis under supervision.
Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends and recommends strategies to improve processes or retrain staff.
Develops and implements protocols for research programs that include strategies and processes to ensure data security and provenance.
Works with the CRU or departmental leadership to ensure that data is shared according to best practices and guidelines.
For studies reporting to the FDA, coordinate the CDISC and CDASH data standard setup and the CDISC dataset transformation tasks.
Under supervision, performs de-identification on allowable data to Safe Harbor standards.
Serves as an expert resource to multiple study teams/research program regarding mapping data flow. Predicts areas of vulnerability in the data flow plan.
Recognizes when 21 CFR Part 11 applies to a project and follows policy related to testing and validation.
Work with biostats and PIs after managing data clean-up and database locks to develop data visualizations (e.g., tables, graphs) for manuscripts and lay summaries.
Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
Under direct supervision from Biostatistician and PI may perform analyses on a variety of data formats and create data analysis plans.
Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.
Operations, Study and Site Management – 35% Effort
For complex scenarios, recognizes when agreements are necessary within the research program.
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits.
Provides oversight, training, and expertise to multiple study teams/research program regarding participant level- documentation for all studies.
Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s).
Maintains study level documentation for all studies.
Records basic protocol information in clinical research management system.
For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.
Prepares studies for closeout and document storage.
Communication– 10% Effort
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.
Leads effective facilitation of team meetings to achieve objectives. Ensures good communication across multiple study teams.
Responsible for developing the study-specific REDCap Communications Portal for each multisite iiT that MiSTiC manages.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Leadership – 5% Effort
Works with the manager to understand areas of opportunity and develop a training plan.
Lead, supervise and manage staff including coaching, time-off, annual performance review, performance management, career development, and training.
Keeps current with advances in the scientific area and considers the impact on the research program.
Keeps self and team current with research updates by attending external offerings; applies learned material on the job.
Plays key/leadership role on committees and workgroups.
Navigates processes and people involved in Duke clinical research, demonstrates organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
Develops and implements solutions that work within the existing leadership or organizational structure.
Demonstrates resilience and actively facilitates the research program through change.
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.
Establishes and assigns the activities of the research program team members to accomplish the study goals.
Ethics – 5% Effort
Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information.
Assists with the development of consent plans and documents for participants.
Develops and submits documentation and information for IRB review.
Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
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.
Minimum Qualifications
Education
Completion of an Associate's degree
Experience
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience.
Preferences
Familiarity and experience with research databases, database builds, data quality management is required.
Experience with the Advarra EDC is helpful but not required.
Significant experience with data management / data quality oversight, reporting, merging databases, SAS or other statistical analysis platforms, data parsimony, QbD principles and familiarity with automated EHR data extraction processes.
Developing and implementing data entry and data management training programs and resources is helpful but not required.
Multisite research coordination helpful but not required.
Job Code: 00001335 CLINICAL DATA MANAGER, SR.
Job Level: 53
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. Our collective 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 Duke University 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.
