Clinical Data Report Programmer

Jobtailor; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Jobtailor in Bengaluru seeks an experienced Clinical Data Management reporting programmer to design, validate and maintain standardized data review reports, profiles, listings and dashboards for participant-level oversight.

You will develop EDC system reports and reusable reporting libraries, translating study specifications into robust programming solutions while ensuring accuracy, reproducibility and data quality across studies in a regulatory compliant environment.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Statistics, Biostatistics, Data Science, Health Sciences, or related field.
• Minimum of 5–7 years' experience in Clinical Data Management report programming within the biopharmaceutical industry or a CRO.
• 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.
• Proficiency in SAS, SQL, Python, R, and JReview.

Responsibilities

• Lead the design, development, validation, and maintenance of standardized CDM reports, patient profiles, and dashboards.
• Develop and maintain EDC system reports and custom reporting solutions for data review and cleaning.
• Create reusable reporting programs and standardized libraries to improve efficiency.
• Translate reporting requirements and study specifications into technical programming solutions.
• Validate programmed reports ensuring outputs are accurate, complete, reproducible, and fit for purpose.
• Maintain reporting programs using version control and appropriate technical documentation.
• Produce ad hoc reports to support study teams, sponsor requests, and data review activities throughout the study lifecycle.
• Collaborate with cross-functional teams to align reporting with Data Management strategies.
• Ensure reporting documentation complies with SOPs, GCP, ICH guidelines, and regulatory requirements.
• Support inspection readiness by maintaining compliant reporting documentation and programming practices.

Skills

English proficiency

Attention to detail

Communication

Education

Bachelor's degree

Tools

SAS

SQL

Python

R

JReview

Job description

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Requirements

• Bachelor's degree (or equivalent education) in Life Sciences, Computer Science, Statistics, Biostatistics, Data Science, Health Sciences, or a related field.
• Minimum of 5–7 years' experience in Clinical Data Management report programming within the biopharmaceutical industry or a Contract Research Organization (CRO).
• 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.