Database Management Analyst

Project Title: Database Management Analyst

Work Experience: 2 to 8 Years

Work location: Bengaluru.

Work Mode: Kochi/Bangalore/Mumbai/Kolkata

Must Have Skills: Clinical SAS/DM SAS/SAS Macros/ SAS Programming (clinical)

edit check, listings

Key Responsibilities:

• Support Clinical Data Management activities within Biometrics.
• Collaborate with programmers, data managers, statisticians, safety, regulatory, and project teams.
• Ensure clinical data quality, accuracy, and consistency.
• Provide programming support as per study timelines and specifications.
• Contribute to data validation and transfer specifications.
• Support clinical data reporting and regulatory submissions.
• Monitor data quality and resolve study data issues.
• Act as Study Clinical Programmer.
• Review work completed by supporting programmers.
• Attend study team meetings and provide inputs.
• Manage delivery timelines.
• Perform ETL (Extract, Transform, Load) of clinical data.
• Generate edit checks, listings, and reports.
• Execute assigned study-related tasks.

Qualifications & Skills

• Bachelor's degree in Mathematics, Computer Science, or equivalent.
• Strong verbal and written communication skills.
• Knowledge of pharmaceutical clinical development and regulatory submissions.
• Understanding of statistical concepts and techniques.
• Experience with clinical data development, validation, and documentation.
• Knowledge of FDA 21 CFR Part 11, EDC, and Clinical Data Management systems.
• Understanding of clinical studies; biomarker data experience is preferred.