Sr Clinical Data Manager
Sr. Clinical Data Manager, MS. deg. in CS., IT., w/ 1 yr. of exp., Perf. quality checks using 360 Data Vali. Prog., Business objects 4.2 & Spotfire comp. tools; Dev. & main. clinical TMF using Veeva Vault, Wingspan, Pulse 2.0 & Rave PDF Generator & ensure DM function are filed; Perf. SAE recon. using Argus Safety Database; Raise & close queries in Medidata Rave, Oracle Inform, Datatrak, Medrio clin. databases; Dev. trial req. spec. & job aid for randomization tools; IWRS or IVRS; Use ODS facility to write custom safety & efficacy reports dir. outputs to PDF & HTML files; Utilize R tool to write code to generate std. graphs for inter. Public. & pres.; Lead, mentor & train team members on dep.process including startup, conduct, closeout act. & change control processes; Dev. Clin. trial study dashboard & timeline using MS Project, Gantt, Visio, & Tableau tools during study start-up; Generate & Rev. CRT packages like Define.xml, XPT files & Reviewers Guide. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.