Senior Clinical Data Manager

PVR Technologies, Inc.   King Of Prussia, PA   Full-time     Administration / Clerical
Posted on November 20, 2021

Senior Clinical Data Manager

Duties: Lead activities for Clinical Data Management deliverables in compliance with CDM standards like CDISC-CDASH and 21 CFR PART 11; Collaborate with medical monitors, clinical team, statisticians to develop electronic case report forms (eCRFs) by using Architect loading spreadsheet (ALS), Study design export (SDE), Data base specification document for collecting clinical trial data; Ensure consistency across studies through close interaction with Clinical Project Team, mentoring/coaching team in reviewing the data using tools like J-Review, I[1]Review, BOXI and Spotfire; Handle Electronic data capture tools like Medidata Rave, Oracle Clinical and Phase Forward in Form, VEEVA CDMS production, Bioclinica; Lead data team in design, build and review of new / update case report forms by using eCRF designing and testing tools such as Sand Box and RAVE architect; Monitor SAS programmers in developing SDTM and ADaM datasets for data analysis to ensure compliance with submission standards; Use Statistical Software like SPSS, Origin Pro 9.0. & programming Languages like SAS (7.1v, 9.1v, 9.3v, 9.4v) for data analysis & data listings generation; Guide study team to create templates and Gantt charts, creating unique formulas using VLOOKUP and HLOOKUP for data listings review. Skills: CDISC-CDASH , J-Review, I-Review, BOXI, Spotfire, Medidata Rave, Oracle Clinical, Phase Forward in Form, VEEVA CDMS production, Bioclinica, Sand Box, RAVE architect, SDTM, ADaM, SPSS, VLOOKUP & HLOOKUP . Skills: CDISC CDASH , J- Review, I- Review, BOXI, Spotfire, Medidata Rave, Oracle Clinical, Phase Forward in Form, VEEVA CDM Sproduction, Bioclinica, Sand Box, RAVE architect, SDTM, ADaM, SPSS, VLOOKUP & HLOOKUP. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.

Requirements: Master’s degree in with 2 years of experience in a job title with similar duties and skills.