Find More Than 10K+
United Kingdom Jobs

Job description

Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Research Data Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.

Overall Position Summary and Objectives

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.

Deliverables:

• 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

Work Details:

• Collects and analyzes data for a variety of studies.
• 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.
• Organizes data to provide functional reporting.
• 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.
• Creates and maintains a variety of reports.
• Create systematic documentation on reporting (completeness, changes or errors).
• Maintain data for past and present studies.
• Maintain databases for tracking and monitoring activities.
• Manages storage and backup systems.
• 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.
• Maintain and improve the existing data pipeline for processing and storing data.
• Participates in the development and design of databases for tracking and statistical purposes that incorporate multiple data fields required by scientists.
• 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.
• 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.
• Assists with coordination of statistical data analysis for numerous ongoing studies by collecting, organizing, and tracking information.
• 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.
• Establish procedure to address inconsistencies and track resolutions.
• Develop data dictionaries for each database.
• Enhance data management and document data sharing practices.
• Manages projects and quickly responds to inquiries about status.
• Perform database analysis to look for incomplete data elements.
• 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.
• Coordinates statistical data analysis for numerous ongoing studies by collecting, organizing, and tracking information.
• 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.
• 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. 3
• Develops and designs databases for tracking and statistical purposes that incorporate multiple data fields required by scientists.
• Develop, maintain and update program database and spreadsheet.
• 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.
• Maintain databases and spreadsheets for tracking and analyzing submission of datasets.
• 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.

1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked

Minimum Education

Bachelor's

Additional Qualifications:

Field of Study

• Miscellaneous Biology
• Biology
• Computer and Information Systems
• Psychology
• Miscellaneous Psychology

Software

• Microsoft Office
• eCRFs, eDC systems
• Microsoft Teams and other electronic meeting platforms

Skills

• Database management
• Data visualization
• Data presentation
• Data annotation
• Data cleaning
• Data mining
• Research

Benefits

• 100% Medical Dental & Vision Coverage for Employees
• Educational Benefits for Career Growth
• Paid Time Off (Including Holidays)
• Employee Referral Bonus
• 401K Matching
• Flexible Spending Accounts:Healthcare (FSA)

Parking Reimbursement Account (PRK)
Dependent Care Assistant Program (DCAP)
Transportation Reimbursement Account (TRN)

Job Type: Full-time

Pay: $95,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Bethesda, MD 20892: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Research Data Managment: 2 years (Required)
• Data QA and Data QC: 2 years (Required)
• FDA regulations: 1 year (Preferred)

Work Location: Hybrid remote in Bethesda, MD 20892