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Clinical Data Manager
Clinical Data ManagerKatalyst HealthCares & Life Sciences • Richmond, VA
Clinical Data Manager

Clinical Data Manager

Katalyst HealthCares & Life Sciences • Richmond, VA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

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 (, CDISC, SDTM) and regulatory requirements (, 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 – years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment.
  • Proficiency in EDC platforms (, 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 (, MedDRA, WHO Drug).
  • Excellent organizational, analytical, and problem-solving skills.
  • Strong communication and collaboration skills across cross-functional teams.

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Clinical Data Manager • Richmond, VA

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