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Precision for Medicine, a global precision medicine clinical research services organization, is seeking a Clinical Data Associate II to support clinical trial data management operations. This role provides comprehensive data management support across the full clinical trial lifecycle, from study startup through post-database lock, working under direct supervision of the Lead Data Manager.
Key responsibilities include: supporting the Lead DM as a backup team member; performing data entry for paper-based CRF studies; conducting quality control reviews of data entry; developing CRF specifications from clinical study protocols; assisting in clinical database builds; conducting database build UAT and maintaining quality documentation; specifying requirements for edit checks (electronic and manual); creating and maintaining data management documentation with appropriate versioning; training clinical research personnel on study-specific CRFs and EDC systems; reviewing and querying clinical trial data per the Data Management Plan; performing line listing data reviews; running patient and study-level status reporting; performing medical coding to ensure logic and consistency; assisting with SAE/AE reconciliation; liaising with third-party vendors (EDC, data vendors) in a project management capacity; assisting with SAS programming and QC; identifying and troubleshooting operational issues; reviewing protocols, SAPs, and CSRs as needed; participating in SOP development; communicating with sponsors, vendors, and project teams; presenting software demonstrations and trainings; and performing other assigned duties.
The ideal candidate holds a Bachelor's degree and has approximately 2 years of clinical data associate experience at a CRO, pharma, or biotech company. Required skills include proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook), ability to manage diverse clinical research tasks, excellent organizational and communication skills, and professional English proficiency (written and oral). Candidates may be based in Hungary, Poland, Romania, Serbia, or Slovakia. Some travel may be required.