Manager, Clinical Data Team
Job Title
Manager, Clinical Data Team
Manager, Clinical Data Team
Date Posted
4/24/2023
4/24/2023
TimeZone
Eastern
Eastern
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Candidate will be responsible for designing, developing, validating, implementing, and maintaining databases used for clinical trials of in vitro diagnostic (IVD) assays. Need experience managing a team.
- The CDM will develop eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g., edit checks), SAE Reconciliation Plan, Data Cleaning Plan, and other DM related documentation.
- Bachelor’s Degree with at least 2 years’ relevant work experience in Clinical Data Management
- Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Data Management is required
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Must have expertise in working with Electronic Data Capture (EDC) systems and clinical data management systems like Medidata Rave and Medrio, as well as thorough knowledge of ICH-GCP and STARD guidelines. The ability to manage, prioritize, and routinely report progress on multiple projects to cross-functional teams and Clinical Management is also required.
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