At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Guidehouse Research Data Manager in Bethesda, Maryland
Job Family :
Data Science & Analysis (Digital)
Travel Required :
Clearance Required :
Ability to Obtain Public Trust
What You Will Do :
We are currently searching for a Research Data Manager. 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 will be responsible managing study data sets, data dictionary, data QA and QC activities and in addition performing testing and verification on the in-house enterprise electronic data capture platform (CiSTAR). The individual will also provide documentation of system defects and will work with the dev ops team to verify bug fixes and new releases. This is a full time onsite position located in Bethesda, MD.
Interview, screen and recruit patients for entry into protocol; contribute to conferences determining who will be accepted into the UDP.
Determine suitability of patients for travel.
Communicates with families and caregivers to obtain medical records; conduct family interviews to obtain comprehensive understanding of the care needs of the patient and family members during travel to and from NIH and throughout the evaluation period.
Assist research and medical staff interview, screen and evaluate the appropriateness of eligible subjects for participation in the research protocol.
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.
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.
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.
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.
Construct systematic processes for data entry and quality assurance from project onset through analysis.
Perform data entry in support of a number of different systems and programs, both numerical and text format.
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, maintain and update program database and spreadsheet.
Participate in the design and implementation of data reporting tools.
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.
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.
What You Will Need :
Minimum of one (1) year of experience.
What Would Be Nice To Have :
Experience in 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
eCRFs, eDC systems
Microsoft Teams and other electronic meeting platforms
What We Offer:
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
401(k) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.