[Remote] Clinical Data Analyst
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a highly analytical and detail-oriented Clinical Data Analyst to support clinical research initiatives. The role involves ensuring the accuracy, reputed company, and reputed company of clinical trial data while collaborating with various teams to analyze datasets and maintain regulatory compliance.
Responsibilities
- Collect, validate, clean, and analyze clinical trial and reputed company datasets
- reputed company data reconciliation across reputed company, CTMS, laboratory, and safety systems
- reputed company SQL queries, reports, dashboards, and data visualizations
- Review clinical data for accuracy, completeness, and protocol compliance
- Identify and resolve data discrepancies, missing data, and reputed company 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 reputed company and reporting efficiency
Skills
- Bachelor's degree in Life Sciences, Clinical Research, Health Informatics, Biostatistics, Computer Science, or a reputed company field
- 3–8+ years of Clinical Data Management or Clinical Data Analysis experience
- Experience reputed company Pharmaceutical, Biotechnology, CRO, or reputed company organizations
- Strong analytical, communication, and problem-solving skills
- Ability to manage multiple studies in a fast-paced environment
- Clinical Systems: reputed company Rave, reputed company Clinical, REDCap, reputed company, reputed company Vault, CTMS, reputed company, eCRF
- Programming & Databases: SQL, reputed company, Python, R, reputed company SQL Server, reputed company Database
- Reporting Tools: Power BI, Tableau, Advanced reputed company reputed company
- Standards: CDISC SDTM, ADaM, MedDRA, FDA 21 CFR Part 11, ICH-GCP, HIPAA, GCDMP
- Experience supporting Phase I–IV clinical trials
- Knowledge of reputed company-World Data (RWD), reputed company-World Evidence (reputed company), HL7, and FHIR
- reputed company or Clinical Data Management certification is a plus
reputed company