Clinical Data Manager oversees clinical data management activities across multiple assigned studies. Performs thorough reviews of critical Clinical Data Management documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans. Performs User Acceptance Testing (UAT) on development of eCRFs and IRT systems during study build and post production changes. Review data transfers for consistency with available specifications. Performs supplemental data reviews according to the data quality checks outlined in the edit check specifications document. Writes clear queries on missing data and data points failing pre-defined range checks and/or logical checks. Participates in reviews of blinded TFL output prior to final database locks. Creates and provides reports on the progress and status of the on-going study data management activities and deliverables, ensuring assigned projects are delivered on track with high quality and accuracy. Contributes to departmental compliance with regulatory and ICH guidelines, GCPs, Standard Operating Procedures, and CDM best practices. Having significant experience, applies advanced data / information management concepts and campus / medical center / OP objectives to resolve highly complex issues where analyses of situations, information or data require an in-depth evaluation of variable factors. Selects methods and techniques to obtain desired results
Job Type: Full-time
Pay: From $80,000.00 per year
- 8 hour shift
- What EDC platforms have you worked on?
- Data management: 3 years (Preferred)
Work Location: Remote