Senior Manager, Clinical Informatics

Role: Senior Manager, Clinical Informatics, overseeing design and management of clinical data workflows, integration, analytics, and visualization to support clinical development. Responsibilities: lead development and maintenance of clinical data systems including IRT/eCOA, translate business needs into scalable reporting and analytics solutions, standardize data processes, manage vendor relationships, and drive adoption of automation and advanced analytics within a GxP environment. Ensure regulatory compliance, support audits, inspections, and continuous improvement initiatives. Collaborate with clinical trial teams and cross-functional stakeholders to optimize data flow and system integration. Qualifications: 7+ years in Clinical Informatics, Data Management, or related fields within biotech/pharma/CRO sectors, with experience in regulated environments, clinical systems (e.g., IRT/eCOA), and data standards (CDISC, SDTM, ADaM). Proficiency in visualization tools like Power BI or Spotfire, cloud technologies, automation, and data governance. Experience supporting global trials, managing external vendors, and ensuring inspection readiness. High-value specifics: focus on clinical data systems, analytics, and visualization in regulated GxP settings supporting early to late-stage clinical development, with an emphasis on compliance, automation, and digital transformation.