Specialists, Clinical Data Management

Primary Responsibilities: Design, build, maintain, test, and document data review based on written specifications. Review technical feasibility of study-team proposed programming/reporting and technically implement; collaborate across teams and communicate issues/ideas while understanding protocol. Support development and reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability. Provide ongoing support for In-Life Reports. Ensure Change Requests and Incident Reports are documented, signed off, tracked, and reported to upper management. Participate in study improvement initiatives (e.g., automation), testing of new systems, and ongoing training/mentoring. Education: Associate degree + 3+ years in clinical data programming/data engineering or related functions, OR Bachelor’s degree + 2+ years in related clinical data programming/data engineering/clinical operations functions, OR Advanced degree preferred (master’s/doctorate) with experience in clinical development and/or related activities. Required Knowledge & Skills: Proficiency in clinical data/reporting systems (e.g., Databricks, Python, SAS, SQL/PL/SQL, Power BI) and AI tools. MS Windows/Office knowledge; exposure to web-based applications. System Development Lifecycle Management/system validation knowledge. Strong relationships, urgency/customer focus, communication with study teams, organization/problem-solving, ability to learn, multitask and work independently. Understanding of drug discovery process, FDA regulations, GxP, and ICH. Required Skills (examples): Clinical Data Management, Communication, Programming, Data Analysis/Quality Assurance, EDC, PL/SQL, SQL databases, team communication. Benefits: comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days. #J-18808-Ljbffr Scorpion Therapeutics