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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 lifecycle of clinical trials, from study startup through post-database lock, working under direct supervision of senior data management leadership.
Key responsibilities include: supporting Lead Data Managers as a backup team member; performing data entry for paper-based Case Report Forms (CRFs); conducting quality control reviews of data entry; developing CRF specifications from clinical study protocols; assisting in clinical database development and testing; conducting database build User Acceptance Testing (UAT); specifying requirements for edit checks and validation rules; creating and maintaining data management documentation with appropriate versioning; training clinical research personnel on study-specific systems and processes; reviewing and querying clinical trial data according to Data Management Plans; performing medical coding to ensure consistency; assisting with Serious Adverse Event (SAE) and Adverse Event (AE) reconciliation; coordinating with third-party vendors including EDC providers; supporting SAS programming and quality control activities; troubleshooting operational issues using metrics and audit data; reviewing protocols, Statistical Analysis Plans, and Clinical Study Reports as needed; participating in SOP development; communicating with sponsors, vendors, and project teams; and presenting software demonstrations and training sessions.
Required qualifications: Bachelor's degree and/or equivalent related experience; approximately 2 years of clinical data management experience at a CRO, pharmaceutical, or biotech company; 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). The role is based remotely and candidates can be located in Hungary, Poland, Romania, Serbia, or Slovakia. Travel may be required occasionally.
