Join to apply for the Clinical Data Manager role at Katalyst CRO 2 days ago Be among the first 25 applicants Location: Austin, TX Salary: $68,500.00 - $217,100.00 Seniority level: Associate Employment type: Contract Job function: Information Technology Industries: Pharmaceutical Manufacturing Responsibilities Oversee, maintain, and ensure the integrity and quality of clinical trial data from collection through database lock. Ensure data accuracy, consistency, and compliance with regulatory and protocol-specific requirements. Collaborate with Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs to support timely and compliant study execution. Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol. Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines. Oversee data cleaning activities, generate, review, and resolve data queries in collaboration with clinical sites and study teams. Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations. Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP). Manage database lock activities and contribute to preparation of clinical study reports (CSRs). Serve as primary point of contact for data management vendors and oversee their deliverables. Participate in study team meetings and provide status updates related to data quality and timelines. Support audit readiness and participate in regulatory inspections when required. Requirements Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field. Minimum of 35 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment. Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap). Strong understanding of ICH-GCP, FDA regulations, and CDISC standards. Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug). Excellent organizational, analytical, and problem‑solving skills. Strong communication and collaboration skills across cross‑functional teams. #J-18808-Ljbffr Katalyst CRO
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