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Sr. Clinical Data Manager
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Full-time
- With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
- Essential FunctionsAct as the Lead Data Manager for one or multiple studies.
- Complete Data Management tasks for assigned studies under minimal supervision according to the study contract and applicable SOPs. Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
- Work with database programmers to design (e)CRFs and edit checks in EDC system.
- Perform data review via listings and EDC system, issue and resolve queries.
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