Join to apply for the Senior Clinical Data Manager role at Katalyst CRO . 7 months ago Be among the first 25 applicants. Responsibilities include: Leading development of clinical data management documentation, including data management plans, CRF designs, data dictionaries, validations, specifications, acceptance criteria, and data transfer agreements. Executing clinical data management activities throughout the study lifecycle, such as supporting site initiation, reconciling data transfers, validating data quality, preparing data for statistical review, performing database lock and freeze activities, archiving study databases, and conducting close-out audits. Serving as liaison with Clinical Affairs to ensure robust data transfer and data quality processes, including data acceptance criteria and transfers. Developing database specifications and ensuring compliance throughout the study, including eCRF design, user requirements, edit rules, query logic, and data validations. Collaborating with study team members across data management, data automation, biostats, and clinical affairs to execute study activities, improve processes, and generate client solutions. Requirements include: Bachelor's degree with 5+ years relevant experience, or master's degree with 3+ years, or doctoral degree with 0-2 years, in Computer Science, Mathematics, Statistics, Pharmaceutical Sciences, Life Sciences, or related fields. Knowledge of EHR and EDC data sources, clinical data management roles, and activities, including CDISC standards and tools like Medidata Rave. Proficiency in Excel, communication, training, data presentation, problem solving, and professional writing. Experience in diagnostic, medical device, or pharmaceutical fields. Experience with programming languages such as R, Python, SQL for data analysis and reproducible research. Understanding of software validation requirements. Knowledge and skills in Medidata Rave. Additional details: Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing This job is active and accepting applications. #J-18808-Ljbffr Katalyst CRO
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