Position Summary The Manager of Clinical Data Management will lead clinical data management activities in support of CRISPR studies across all stages of clinical development, ensuring accurate, consistent, high-quality, and complete data. Responsibilities Plan, coordinate, and manage data management tasks and timelines. Serve as primary liaison with CROs, third-party data vendors, and EDC vendors. Collaborate with internal clinical study teams to address stakeholder needs. Primary author/approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, coding plans, data management plans, and third-party vendor data specifications. Oversee database design, production, and UAT cycles to ensure CRO quality standards. Accountable for external data vendor documentation, management, and reconciliation. Contribute to departmental SOP/process development, improvement, and technology integration. Perform and/or review medical coding and SAE reconciliation. Support internal review/QC of clinical data. Support GCP inspection readiness. Minimum Qualifications Bachelor’s degree in a health‑related field (Master’s degree strongly preferred). 7+ years of progressive clinical data management experience in a regulatory environment. Demonstrated proficiency managing the lifecycle of clinical data projects. Experience developing reports using J-Review, Business Objects, or other CDM reporting tools. EDC database experience (especially Medidata Rave). CDASH/SDTM/CDISC standards experience. Experience working with central and specialty labs/vendors. Working knowledge of medical terminology and coding dictionaries (MedDRA, WHO). Familiarity with GCP, ICH, and FDA requirements as applicable. Ability to manage multiple initiatives and shifting priorities in a fast‑paced environment. Strong analytical and problem‑solving skills. Excellent interpersonal, independent and collaborative work skills. Excellent written and oral communication skills. Preferred Qualifications Prior experience in a small or medium‑sized biotech or pharmaceutical company. #J-18808-Ljbffr Scorpion Therapeutics
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