Sr Clinical Data Manager

Sr. Clinical Data Manager, MS. Deg. in Econ., Bus., Admn., w/ 2 yrs. of exp.; Inst. team to write edit check spec.& prog. edit checks into EDC sys. in colla. w/ EDC des. to set-up query mngt. & data cleaning pro.; Guide team to perf. UAT of prog. edit checks, draft database screen spec. & des. database screens in colla. w/ EDC des. in diff. study databases, incl. Medidata RAVE, Veeva EDC, Oracle Clinical RDC & Phase forward Inform; Mon. team to write & prog. SAS checks & gen. SAS listings to rev. & analyze data, using SAS prog.; Prog. & set up Xcellerate data rev. tools, including PST & SST, & lead team to prepare DM metrics & status rep. using PST & SST tools; Inst. team to raise/close queries in EDC sys., & keep track of open/closed queries in DRTM; Perf. Grap. analysis of clin. data using reporting tools, including J-Review & JMP, & prepare trend & ratio analysis reports; Lead team to analyze & rev. coding reports gen. using MedDRA & WHO Drug Dictionary; Lead data mngt.activities & ensure that data is cleaned & reported per ICH-GCP, GCDMP & 21 CFR Part 11 guide. & FDA reg. & std., using CDISC, CDASH & SDTM; Prep. data transfer spec. & set up integ. of data from third party vendor databases; IRT/IxRS & ePRO; Archive/file study doc. into eTMF using Veeva Vault platf., & ensure insp. readiness of doc. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.Send Resume to PVR Technologies, Inc, 501 Allendale RD, Ste 201, King of Prussia, PA 19406. recblid fhmnedxk8giitfeo88ujvl0lpcpwfu