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.