Quality Assurance / Quality Control Data Specialist, Senior

LCG, Inc.
$111,600.00 - $136,500.00 / yr
retirement plan
United States, Maryland, Maryland
Apr 30, 2025
This job opportunity is part of an RFP process; candidates are invited to submit their resumes detailing relevant experience. Job Title - Quality Assurance / Quality Control Data Specialist, Senior Job Summary - The QA/QC Data Specialist supports the client by ensuring high-quality, standardized, and interoperable data management processes across multiple study sites. This role focuses on verifying study data accuracy, developing and maintaining validation tools, ensuring compliance with federal data protection requirements, and generating ongoing QA/QC reports. The QA/QC Data Specialist will work closely with the client development and data management teams, Vaccine Centers, and external collaborators to maintain the integrity and quality of diverse, complex datasets. Key Responsibilities Data Quality Assurance and Control Develop, maintain, and execute quality control procedures to verify 100% of study data. Design and implement automated data validation and error-checking processes. Conduct ongoing QA/QC audits, generating summaries of errors and inconsistencies. Develop strategies for standardized data collection across multi-site studies. Identify and flag aberrant or missing data; coordinate with data submitters to address issues. Generate and deliver regular QA/QC reports to internal and external stakeholders. Assist with de-identification and anonymization of human subject data in compliance with HIPAA, Common Rule, and NIH guidelines. System and Documentation Management Maintain version control for user guides, documentation, and software/database updates. Develop and update SOPs for data collection, validation, editing, and storage processes at least annually or as needed. Participate in system documentation aligned with DHHS Enterprise Performance Life Cycle (EPLC) and federal standards. Interoperability and Compliance Support the adoption of FAIR data-sharing principles. Facilitate data integration with external systems such as ImmPort, IEDB, CEIRR, and other NIAID-supported repositories. Ensure data management activities adhere to FISMA, HIPAA, and NIH Data Management and Sharing Policy requirements. Program Support Support the client portal team in tracking and visualizing study status and data summaries. Collaborate with vaccine center teams to ensure timely data submission, QC checks, and resolution of issues. Contribute to training sessions and documentation for investigators and stakeholders on DMCC processes. Qualifications Bachelor's degree in Life Sciences, Data Science, Public Health, Information Management, Computer Science, or a related field. 2-5 years of experience in data quality assurance/control, preferably in biomedical research or clinical study environments. Experience with data systems associated with biomedical research (e.g., ImmPort, CEIRR, IEDB, BRCs) preferred. Experience working in a multi-site, multi-disciplinary research environment preferred. Familiarity with automated testing frameworks and data validation scripting (Python, R, or similar). Certification in quality management systems (e.g., Six Sigma, CQA) is a plus. Knowledge of HIPAA, Common Rule, FISMA compliance, and NIH data management policies. Experience with relational database systems and query languages (e.g., SQL). Familiarity with data standardization, data cleaning, and interoperability concepts (e.g., FAIR principles). Strong attention to detail and commitment to data integrity. Experience documenting SOPs and maintaining version-controlled documentation. Proficiency with data visualization and reporting tools (e.g., Tableau, Power BI, or equivalent) a plus. Compensation and Benefits The projected compensation range for this position is $111,600 to $136,500 per year benchmarked in the Washington, D.C. metropolitan area. The target salary is $123,700 for this role. The salary range provided is a good faith estimate representative of all experience levels. Salary at LCG is determined by various factors, including but not limited to role, location, the combination of education/training, knowledge, skills, competencies, certifications, and work experience. LCG offers a competitive, comprehensive benefits package which includes health insurance options (medical, dental, vision), life and disability insurance, retirement plan contributions, as well as paid leave, federal holidays, professional development, and lifestyle benefits. Devoted to Fair and Inclusive Practices All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. If you are interested in applying for employment with LCG and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department by email at hr@lcginc.com. Securing Your Data Beware of fraudulent job offers using LCG's name. LCG will never request payment-related details or advancement of money during the application process. Legitimate communication will only come from lcginc.com or system@hirebridgemail.com emails, not free commercial services like Gmail or WhatsApp. If you receive suspicious emails asking for payment or personal information, contact us immediately at hr@lcginc.com. If you believe you are the victim of a scam, contact your local law enforcement and report the incident to the U.S. Federal Trade Commission.