Position Objective: Provide services as a Research Data Manager in support of the overall functions of the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). The NINDS at the NIH located in Bethesda, Maryland is looking for a data manager responsible for assisting the study team by developing electronic research databases and all needed forms, as well as ensuring data is accurate and compliant. This individual hired for this position is responsible managing study data sets, data dictionary, data QA and QC activities and in addition performing testing and verification on the inhouse enterprise electronic data capture platform (CiSTAR). The incumbent will also provide documentation of system defects and will work with the dev ops team to verify bug fixes and new releases.

Duties and Responsibilities:

• Construct systematic processes for data entry and quality assurance from project onset through analysis. 5
• Perform data entry in support of a number of different systems and programs, both numerical and text format.
• Work with staff to gather and analyze information from users, primarily principal investigators (PIs), needed for the development or modification of CRFs and accompanying interface relating to data collection, storage and access. 2
• Coordinate and perform data entry.
• Perform quality checks to ensure consistency, integrity and robustness of data.
• Create data workflow processes.
• Ensure that appropriate variables are captured in the constructed databases.
• Format databases to allow merging of spreadsheets for statistical analyses and to optimize planned analyses. Record data into a format appropriate for processing.
• Provide support with data sharing, including public repositories. Work with staff to prepare and standardize data for the database. Perform routine and general data management.
• Perform database searches and assemble data sets.
• Create systematic documentation on reporting (completeness, changes or errors). Maintain data for past and present studies.
• Maintain databases for tracking and monitoring activities.
• Maintain and improve the existing data pipeline for processing and storing data.
• Maintain and update electronic copies of all databases and data dictionaries developed for projects. Maintain and update accurate and complete filing of data following data entry / QA.
• Perform data auditing for quality assurance of data entry review.
• Follow established policies and procedures for the quality assurance of all study collection interfaces, storage and access.
• Develop and maintain data management and quality assurance/quality control procedures that improve the transparency, consistency, accuracy and comparability of data which supports the integrity of research. 4
• Develop, maintain and update program database and spreadsheet. Participate in the design and implementation of data reporting tools.
• Provide support for requests pertaining to new studies for electronic data capture or storage from investigators, review of current system or the creation and editing of CRFs and electronic capture tools/interface. 1
• Maintain databases and spreadsheets related to various data sharing activities.
• Provide support for all data sharing related activities; create and maintain data access and data submission tracking systems and reports to be presented to senior program leadership.
• Maintain databases and spreadsheets for tracking and analyzing submission of datasets. Facilitates interactions between parties involved in data sharing activities.
• Develops a library of standardized protocol language that can be applied across rare neuromuscular disease studies.
• Develop data management plans for each study at time of study start-up, assuring that workflow, data capture, quality control, reporting, and sharing procedures are in place.
• Assist with the development of Common Data Elements for team studies.
• Implement and disseminate regulatory changes and updates affecting data management procedures.
• Establish procedure to address inconsistencies and track resolutions. Develop data dictionaries for each database.
• Enhance data management and document data sharing practices.
• Formulate appropriate data auditing plan and strategy to provide services to studies that are active and ongoing as required to ensure that the quality of the data meets the study goals and quality standards.
• Prepare databases and reports for staff; perform various tracking and analysis of branch data to include spreadsheet preparation and interpretation.
• Assist researchers with query resolution for external sponsors.
• Works with IT, database developers, and investigators to ensure the database and associated forms/eCRFs capture all data delineated in protocols, and can be practicably captured within the database. 3
• Track and solve problems during the data entry and QA processes.
• Provide description of procedures used to perform data quality assurance; update as procedures are developed. Allocate quality assurance resources to ensure data validity and fidelity.
• Work with database users to identify and resolve cases of missing data. Perform database analysis to look for incomplete data elements.
• Work with IT, database developers, and investigators to ensure the database and associated forms/eCRFs capture all data delineated in protocols, and can be practicably captured within the database.
• Facilitate interactions between parties involved in data sharing activities.
• Develop a library of standardized protocol language that can be applied across rare neuromuscular disease studies. Develop data management plans for each study at the time of study startup, assuring that workflow, data capture, quality control, reporting, and sharing procedures are in place.
• Assist with the development of Common Data Elements for team studies.
• Implement and disseminate regulatory changes and updates affecting data management procedures.
• Work product and documents related to providing platform-independent data management support across the NINDS IRP; develop data management plans for all studies as needed (existing studies) and at the time of study startup (new studies) to ensure that workflow, data capture, quality control, reporting, and sharing procedures are in place. - Daily
• Work product and documents related to research data and management reports, retrieval of data from databases and other data sources, and performing regular reporting on trial progress and data capture status. - Weekly
• Work product and documents related to data quality processes and procedures, including but not limited to ensuring data quality, accuracy and completeness, adherence to data management plans and applicable regulations, ensuring all study outcome measures are captured including facilitating the translation of procedures/tests into a practicable data capture system, creating and performing Quality Control (QC) checks. - Weekly
• Work product and documents related to ensuring all NIH, Federal and other regulations are followed, including but not limited to keeping abreast of changes and updates related to data management procedures, educating study staff related to current and changing regulations, updating affected data management procedures to be in line with regulations, instructing staff regarding data management procedures. - Ad-Hoc
• Work product and documents related to development of data and study language libraries specific to the study team/protocols, and development of Common Data Elements for the study team trial focus. - Ad-Hoc
• Work product and documents related to directly entering or assisting/instructing staff in data entry. - Ad-Hoc
• Meet with lab members to present updates - Weekly

Basic Qualifications:

• Bachelor's degree in miscellaneous biology, computer and information systems, psychology, management information systems and statistics, computer programming and data processing, community and public health, computer science, information sciences, or statistics and decision science.
• Skilled in Microsoft Office, eCRFs, eDC systems, Microsoft Teams, and other electronic meeting platforms.
• Experienced in database management, data visualization, data presentation, data annotation, data cleaning, data mining, and research.

Minimum Qualifications:

• Ability to multi-task and pay close attention to detail.
• Excellent analytical, organizational and time management skills.
• Strong communication skills, both oral and written.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.