What are the responsibilities and job description for the Associate Clinical Data Manager position at Katalyst CRO?
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).
- 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.