Clinical Data Analyst

About the Role

We are looking for a meticulous and analytical Clinical Data Analyst to contribute to clinical research projects by ensuring the precision, integrity, and high quality of clinical trial data. This role involves close collaboration with teams in Clinical Operations, Biostatistics, Data Management, and Regulatory to analyze datasets, maintain compliance with regulations, and provide insights to support clinical study success.

Key Responsibilities

• Collect, validate, clean, and analyze clinical trial and healthcare data sets.
• Conduct data reconciliation among Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), laboratory, and safety databases.
• Create SQL queries, reports, dashboards, and visual data representations.
• Review clinical data for accuracy, completeness, adherence to protocols.
• Detect and correct data discrepancies, address missing data and quality problems.
• Assist in database lock processes, data validation, user acceptance testing, and study closure activities.
• Prepare datasets for statistical evaluation and regulatory submissions.
• Engage with Clinical Operations, Biostatistics, Medical Affairs, and Regulatory groups.
• Ensure regulations compliance including FDA 21 CFR Part 11, ICH-GCP, HIPAA, and CDISC guidelines.
• Propose improvements to processes for better data quality and efficiency in reporting.

Required Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, Health Informatics, Biostatistics, Computer Science, or similar fields.
• Between 3 to 8+ years of experience in Clinical Data Management or Data Analysis.
• Experience within Pharmaceutical, Biotechnology, CRO, or Healthcare sectors.
• Highly developed analytical, communication, and problem-solving abilities.
• Capacity to handle multiple clinical studies in a demanding environment.

Technical Skills

• Familiarity with clinical systems such as Medidata Rave, Oracle Clinical, REDCap, OpenClinica, Veeva Vault, CTMS, EDC, and electronic Case Report Forms (eCRF).
• Proficiency in programming and database management including SQL, SAS, Python, R, Microsoft SQL Server, and Oracle Database.
• Experience with reporting tools such as Power BI, Tableau, and advanced Microsoft Excel.
• Knowledge of standards including CDISC SDTM, ADaM, MedDRA, FDA 21 CFR Part 11, ICH-GCP, HIPAA, and GCDMP.

Preferred Qualifications

• Experience supporting Phase I through IV clinical trials.
• Understanding of Real-World Data (RWD), Real-World Evidence (RWE), HL7, and FHIR standards.
• Certifications in SAS or Clinical Data Management are advantageous.