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Associate Clinical Data Manager
Associate Clinical Data ManagerKatalyst Healthcares and Life Sciences • Boulder, CO, United States
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Associate Clinical Data Manager

Associate Clinical Data Manager

Katalyst Healthcares and Life Sciences • Boulder, CO, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
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Responsibilities:
  • ssist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs).
  • Support database setup activities including edit check specifications and user acceptance testing (UAT).
  • Review incoming clinical data for completeness, consistency, and accuracy.
  • Generate, track, and resolve data queries in collaboration with clinical sites.
  • Maintain study documentation and data management files.
  • Participate in cross-functional study team meetings and data review discussions.
  • Support Serious Adverse Event (SAE) reconciliation and external data reconciliation (e.g., labs, central imaging).
  • Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC).
Requirements:
  • Bachelor's degree in a life science, health science, pharmacy, public health, or related field.
  • Strong attention to detail, organizational, and time management skills.
  • Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint).
  • Effective written and verbal communication skills.
  • bility to learn and apply technical systems and software (EDC, CTMS, etc.).
  • Familiarity with clinical trial processes and Good Clinical Practice (GCP).
  • Experience with EDC systems (e.g., Medidata Rave, Veeva Vault, Medrio) a plus.
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Associate Clinical Data Manager • Boulder, CO, United States

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