Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.
Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics
March 18
Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.
Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics
• Utilize the Elluminate platform to support clinical data integration, analysis, and reporting needs for clinical trials. • Write and maintain code for clinical trial data processes, including data extraction, transformation, and analysis using the Elluminate programming environment. • Ensure accurate and timely delivery of clinical trial data by performing data checks, validation, and reconciliation in line with clinical trial timelines and regulatory requirements. • Work closely with clinical data managers, statisticians, and other stakeholders to design and implement clinical data flow, ensuring compliance with all regulatory requirements. • Identify, investigate, and resolve any issues that arise within the Elluminate platform or clinical data programming processes. • Maintain comprehensive documentation of programming processes, code, and data management workflows for audit and regulatory purposes. • Contribute to the improvement of programming practices, tools, and templates to streamline clinical programming workflows and enhance efficiency. • Provide guidance and mentorship to junior programmers, ensuring adherence to best practices and facilitating knowledge sharing within the team.
• 4-6 years of experience in clinical programming, specifically working with the Elluminate platform in a clinical trial environment. • Proficient in clinical data programming languages (e.g., SAS, R, SQL, etc.). • Expertise in the Elluminate platform, including experience with clinical data workflows, data integration, and programming solutions. • Strong knowledge of clinical trial data structures, data standards (e.g., CDISC, SDTM), and regulatory requirements (e.g., FDA, EMEA). • Excellent troubleshooting and problem-solving skills with the ability to work under pressure to meet deadlines. • Strong communication skills with the ability to collaborate effectively with cross-functional teams and communicate technical concepts to non-technical stakeholders. • Bachelor’s degree or higher in Computer Science, Life Sciences, Engineering, or related field (or equivalent work experience).
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