Clinical Data Report Programmer (India)

Exciting Opportunity in India!

Clinical Data Report Programmer

Minimum Requirements

Bachelor's degree (or equivalent education) in Life Sciences, Computer Science, Statistics, Biostatistics, Data Science, Health Sciences, or a related field.

• Experience:
• Minimum of 5–7 years' experience in Clinical Data Management report programming within the biopharmaceutical industry or a Contract Research Organization (CRO).
• Skills & Competencies:
• High-level English language proficiency.
• Strong understanding of Clinical Data Management principles, workflows, and clinical trial data review processes.
• Extensive knowledge of clinical database structures and Electronic Data Capture (EDC) systems.
• Experience developing and maintaining EDC system reports , clinical data review reports, patient profiles, listings, dashboards, and data cleaning reports.
• Ability to interpret clinical study protocols, edit check specifications, data review plans, and reporting requirements.
• Proficiency in SAS, SQL, Python, R, and JReview .
• Experience working with multiple clinical data sources, external data, and reconciliation datasets.
• Strong understanding of CDISC standards, including SDTM and controlled terminology (preferred).
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Strong analytical, problem-solving, and troubleshooting skills.
• Excellent attention to detail with a commitment to data quality, integrity, and accuracy.
• Ability to manage multiple studies and competing priorities simultaneously.
• Strong organizational and time management skills.
• Excellent written and verbal communication skills with the ability to collaborate effectively across cross-functional teams.
• Proficiency in Microsoft Office Suite.
• Experience performing report validation, quality control, and technical documentation.

RESPONSIBILITIES

Clinical Data Reporting

• Lead and contribute to the design, development, validation, and maintenance of standardized Clinical Data Management reports, patient profiles, listings, dashboards, and visualizations to support participant-level clinical data review.
• Develop and maintain EDC system reports and custom reporting solutions that support ongoing data review, operational oversight, and data cleaning activities.
• Create reusable reporting programs and standardized reporting libraries to improve efficiency and consistency across studies.
• Translate Data Management reporting requirements, Data Review Plans, and study-specific specifications into technical programming solutions.
• Validate programmed reports and ensure outputs are accurate, complete, reproducible, and fit for purpose.
• Maintain reporting programs using version control and appropriate technical documentation.

Clinical Data Review & Data Cleaning Support

• Develop reports that support ongoing clinical data review, discrepancy management, query management, risk identification, and data cleaning activities.
• Produce patient profiles, exception reports, trend reports, missing data reports, protocol deviation reports, and other operational review listings.
• Support Clinical Data Managers by developing reports that identify data inconsistencies, edit check trends, missing or overdue data, and site-specific data quality issues.
• Develop reports supporting reconciliation of external data (e.g., laboratory, ECG, imaging, ePRO, and other vendor data) where applicable.
• Produce ad hoc reports to support study teams, sponsor requests, and data review activities throughout the study lifecycle.

Cross-Functional Collaboration

• Collaborate closely with Clinical Data Management, Clinical Operations, Medical Monitoring, Biostatistics, Statistical Programming, and external vendors to understand reporting requirements.
• Participate in study startup activities to define reporting requirements and ensure reporting solutions align with Data Management strategies.
• Provide technical expertise on reporting capabilities, EDC reporting functionality, and data visualization best practices.
• Support the resolution of reporting issues and recommend improvements to reporting processes.

Documentation & Compliance

• Develop and maintain programming specifications, report validation documentation, user guides, and technical documentation.
• Ensure reporting documentation complies with organizational SOPs, Work Instructions, and quality standards.
• Maintain complete documentation for report development, testing, validation, and deployment.

Quality Control & Regulatory Compliance

• Ensure all reporting activities comply with applicable SOPs, GCP, ICH guidelines, and regulatory requirements.
• Perform quality control and peer review of reporting programs and outputs.
• Support inspection and audit readiness by maintaining compliant reporting documentation and programming practices.
• Ensure all reports accurately reflect current clinical database content and meet Data Management quality expectations.

Process Improvement & Innovation

• Drive standardization of Clinical Data Management reporting across studies through reusable templates, macros, and automation.
• Identify opportunities to automate routine reporting processes using SAS, SQL, Python, R, JReview, and EDC reporting capabilities.
• Evaluate new reporting tools and technologies to improve Clinical Data Management efficiency and participant-level data review.
• Contribute to continuous improvement initiatives focused on Data Management reporting, data visualization, and operational oversight.

Knowledge Sharing

• Provide technical guidance and support to junior programmers and Clinical Data Management team members.
• Share reporting standards, programming best practices, and technical expertise across project teams.
• Support the development of reporting standards, documentation, and internal training materials.