BioForum

Software Engineer

• 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.

Clinical Data Report Programmer

Clinical Specialist

• Demonstrate strong work ethic, commitment, and a commitment to quality
• Foster a cohesive and motivated data management team
• Supervise and lead Clinical Data Specialists
• Support the Clinical Data Strategy Lead in driving timelines and deliveries
• Coordinate data reviews by assigning tasks and responsibilities to team members
• Ensure adherence to established Business Practices, Standard Operating Procedures, and Working Instructions
• Review study specific protocols and provide input in the design of eCRF
• Lead and direct the development and implementation of Data Cleaning Listings
• Actively contribute to the development of the study specific Data Management documentation
• Independently oversee data reviews for studies
• Serve as escalation point for unresolved data issues
• Pro-actively identify and manage risks on assigned projects
• Support with holistic data reviews and provide insights on Data Trends, Risks and Anomalies
• Maintain accurate and up-to-date project documentation
• Generate project-related reports and metrics to monitor project performance
• Ensure timely and appropriate filing of all Data Management project documentation
• Ensure clinical trial data completeness, integrity, and consistency
• Implement and execute robust quality control procedures

Clinical Data Report Programmer

Senior Clinical Data Specialist