About the Role
We are seeking a highly analytical and detail-oriented Clinical Data Analyst to support clinical research initiatives by ensuring the accuracy, integrity, and quality of clinical trial data. The ideal candidate will collaborate with Clinical Operations, Biostatistics, Data Management, and Regulatory teams to analyze clinical datasets, maintain regulatory compliance, and deliver actionable insights that support successful clinical studies.
Key Responsibilities
Collect, validate, clean, and analyze clinical trial and healthcare datasets.
Perform data reconciliation across EDC, CTMS, laboratory, and safety systems.
Develop SQL queries, reports, dashboards, and data visualizations.
Review clinical data for accuracy, completeness, and protocol compliance.
Identify and resolve data discrepancies, missing data, and quality issues.
Support database lock, data validation, UAT, and study closeout activities.
Prepare datasets for statistical analysis and regulatory submissions.
Collaborate with Clinical Operations, Biostatistics, Medical Affairs, and Regulatory teams.
Ensure compliance with FDA 21 CFR Part 11, ICH-GCP, HIPAA, and CDISC standards.
Recommend process improvements to enhance data quality and reporting efficiency.
Required Qualifications
Bachelor's degree in Life Sciences, Clinical Research, Health Informatics, Biostatistics, Computer Science, or a related field.
3–8+ years of Clinical Data Management or Clinical Data Analysis experience.
Experience within Pharmaceutical, Biotechnology, CRO, or Healthcare organizations.
Strong analytical, communication, and problem-solving skills.
Ability to manage multiple studies in a fast-paced environment.
Technical Skills
Clinical Systems: Medidata Rave, Oracle Clinical, REDCap, OpenClinica, Veeva Vault, CTMS, EDC, eCRF
Programming & Databases: SQL, SAS, Python, R, Microsoft SQL Server, Oracle Database
Reporting Tools: Power BI, Tableau, Advanced Microsoft Excel
Standards: CDISC SDTM, ADaM, MedDRA, FDA 21 CFR Part 11, ICH-GCP, HIPAA, GCDMP
Preferred Qualifications
Experience supporting Phase I–IV clinical trials.
Knowledge of Real-World Data (RWD), Real-World Evidence (RWE), HL7, and FHIR.
SAS or Clinical Data Management certification is a plus.

Clinical Data Analyst

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