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Clinical Data Manager

Katalyst Healthcares and Life Sciences

Responsibilities:
  • The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock
  • The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements
  • This role collaborates closely with cross-functional teams, including 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, including the generation, review, and resolution of 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 the preparation of clinical study reports (CSRs)
  • Serve as the 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 3-5 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
Vacancy posted 2 days ago
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