Associate Clinical Data Manager

Katalyst Healthcares & Life Sciences

Lake County, IL

JOB DETAILS
SKILLS
Acceptance Testing, Adverse Events, Biology, Case Report Form (CRF), Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Trial, Communication Skills, Cross-Functional, Data Management, Data Quality, Database Administration, Detail Oriented, Documentation, Electronic Data Capture (EDC), GCP (Good Clinical Practices), Health Science, ICH Regulations, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Pharmacy, Presentation/Verbal Skills, Public Health, Reconciliation, Regulations, Research Protocols, Standard Operating Procedures (SOP), Test Plan/Schedule, Time Management, Writing Skills
LOCATION
Lake County, IL
POSTED
30+ days ago
Responsibilities:
  • Assist 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
  • Ability 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

About the Company

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Katalyst Healthcares & Life Sciences