Database Management Analyst (Clinical SAS Programming)

IQVIA; Kolkata District, Bengaluru, Mumbai; Hybrid; INR 600,000 - 1,200,000; Full time

Job summary

IQVIA is seeking a Database Management Analyst to support clinical data management activities within Biometrics. The role involves ETL of clinical data, generating edit checks and listings, and ensuring data quality across studies.

The position requires 2 to 8 years of experience, a background in mathematics or computer science, knowledge of FDA 21 CFR Part 11, EDC, and CDMS, and strong communication skills. The work is hybrid with locations across Kochi, Bangalore, Mumbai, and Kolkata.

Qualifications

• 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.

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 of clinical data.
• Generate edit checks, listings, and reports.
• Execute assigned study-related tasks.

Skills

Communication skills

Statistical concepts

Clinical data management

Pharma regulatory knowledge

Biomarker data experience

Education

Bachelor's degree in Mathematics/Computer Science or equivalent

Tools

Clinical SAS/DM SAS/SAS Macros

SAS Programming (clinical)

EDC

CDMS

Job description

Project Title: Database Management Analyst

Work Experience: 2 to 8 Years

Work location: Kochi/Bangalore/Mumbai/Kolkata

Work Mode: Hybrid

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.