Associate Clinical Data ManagerKatalyst HealthCares & Life Sciences • Detroit, MI
Associate Clinical Data Manager
Katalyst HealthCares & Life Sciences • Detroit, MI
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job_description.job_card.job_descriptionBachelor'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 (, Medidata Rave, Veeva Vault, Medrio) a plus.
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 (, labs, central imaging).
- Ensure data management activities follow SOPs, study protocols, and regulatory standards (, ICH-GCP, CDISC).
Requirements :
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