Shionogi Inc.
Principal Data Manager (Project Management)
Principal Data Manager (Florham Park, NJ) – Manage all in-house data activities in coordination with biostatistics, clinical, and medical research groups; Perform review of Clinical Study Protocols and lead clinical study database (Medidata Rave) design; Develop eCRFs and create specifications for clinical study database and edit check specifications using eTMF; Develop Data Management Plans (DMP) and Data Review Specifications (DRS); Respond to and provide trail related support to cross-functional groups such as biostatistics and medical groups using Project Management; Lead and coordinate Blinded Interim Data Review (BIQR) process; Develop data review reports/Objects, patient profiles, study specific status reports and dashboards using JReview, SAS/BASE, Tibco spotfire and BOXI reporting systems; Develop and analyze Data Transfer Specifications and data reconciliation for IxRS, ePRO, Central and Local labs; Set up EDC (Electronic Data Capture) system.
Must have a Master's degree Statistics, Biostatistics, or Information Studies plus 1 year experience in job offered or as Clinical Data Coordinator. Require skills and knowledge of Medidata Rave, eCRF, JReview, Tibco/Spotfire, SAS, Project Management, IxRS/ePRO.
Job location: Florham Park, NJ. Send rés w/code CHG001 2 to HR, Shionogi, Inc, 300 Campus Dr, Florham Park, NJ 07932.
(BIQR) process; Develop data review reports/Objects, patient profiles, study specific status reports and dashboards using JReview, SAS/BASE, Tibco spotfire and BOXI reporting systems; Develop and analyze Data Transfer Specifications and data reconciliation for IxRS, ePRO, Central and Local labs; Set up EDC (Electronic Data Capture) system.
Must have a Master's degree Statistics, Biostatistics, or Information Studies plus 1 year experience in job offered or as Clinical Data Coordinator. Require skills and knowledge of Medidata Rave, eCRF, JReview, Tibco/Spotfire, SAS, Project Management, IxRS/ePRO.
Job location: Florham Park, NJ.
Clinical Development