KH
Associate Clinical Data Manager
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Manager or above
7 months ago
- ICH-GCP
- CDISC
- Excel
- PowerPoint
- GCP
- Veeva Vault
7 months ago
- 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)
- 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
Associate Clinical Data Manager · Katalyst Healthcares & Life Sciences