Clinical Data Manager, Senior

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

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 Preformed

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. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke.

• Develops and implements protocols for research programs that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke.

• Works with the CRU or departmental leadership to ensure that data is shared according to best practices and guidelines. For multiple study teams, provide guidance on the use of data standards. Provides training and oversight into EDC creation using appropriate data standards.

• 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. Determines areas where data provenance may be compromised and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke.

• Recognizes when 21 CFR Part 11 applies to a project and follows policy related to testing and validation. Provides oversight and training to multiple study teams on validation and testing for EDCs.

• 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. 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 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. Facilitates the process by coordinating with study teams and appropriate Duke offices.

• 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.

• 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, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing.

• Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program.  Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance.

• Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams.

• 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.

• Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others.

• Prepares studies for closeout and document storage. May train or oversee others.

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, and mentors staff to improve communication strategies.

• 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. Takes training courses and applies the knowledge and skills. May also train others in the skills learned.

• 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. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others.

• 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 - clinical experience is not necessary or 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

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