CLINICAL DATE ENGINEER Clinical Data Engineer with Boehringer Ingelheim Pharmaceuticals, Inc.

in Ridgefield, CT. Serve as a key liaison / Clinical Data Mgmt (CDM) lead to establish, align, & confirm data mgmt expectations for assigned trial(s), reqg regular interaction w/ other internal & external partners. Position reqs a Bach deg (US or foreign equiv) in Life Scis, Regulatory Affairs, Comp Sci, or a rel field & 3 yrs exp in the job offered or in a rel role. Must have exp w/: leading end-to-end clinical data mgmt activities (incl database spec, trial conduct & closeout) using the electronic data capture (EDC) system (Medidata Rave); transforming data reqs of the clinical trial protocol into EDC data collection case report forms in compliance w/ CDISC (SDTM) standards; transforming external data reqs of the clinical trial protocol into Data Transfer Agreements (DTAs); creating EDC data validation (cleaning) specs; creating manual data review listings & tables in tools such as JReview or SAS to ensure quality data for the trial; participating in Trial Oversight Meetings w/ cross functional study team members to ensure ongoing review of trial conduct & data quality; serving as the primary point of contact for CRO oversight for database building, data cleaning, query mgmt & SDTM transformation; ensuring the overall trial data quality is fit for purpose, incl Regulatory (SDTM) compliance; maintaining Clinical Data Mgmt (CDM) rel study documents incl Data Mgmt Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines & other study documents to ensure data quality & data standardization; Project Mgmt; providing recommendations to implement new technologies resulting in process improvements; using MedDRA & WHODrug; understanding & complying w/ the principles of ICH GCP guidelines, global regulatory reqs, & industry standards applicable to data capture & data mgmt process; & working w/ MS Office Suite (Excel, Word, & PowerPoint), EDC tools such as Medidata, & Data review tools such as SAS & JReview. *Telecommuting permitted: Work may be performed w/in normal commuting distance from Boehringer Ingelheim Pharmaceuticals, Inc.’s office in Ridgefield, CT. Qualified Applicants: To apply visit www.boehringer-ingelheim.us/ careers. Click on careers & apply (under jobs), enter #2216359 into the keywords field. Click on the Clinical Data Engineer, scroll to the bottom of the page & click on apply online to submit your application.