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.