Vacancy Description
Responsibilities:
Requirements:
- 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:
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