Quality Systems Specialist (20-00067) – NJ – Woodcliff Lake

Summary:
Responsible for the quality checks of clinical study as they relate to data collection and cleaning, from study start up through ongoing oversight to completion.
Develop essential Procedural documents, Data Review Plans and Data Clean Listings.
Perform user acceptance testing and review protocols and develop scripts.
Develop and lead training, user acceptance testing and review protocols to ensure consistency.
Work with data management and clinical study teams in the development and activities related to edit check listings, review listings, statistical analysis for ongoing clinical studies.
Plans and establishes approaches for coding programs and implement best practices for program documentation.
Interacts with various Data Operations, Statisticians, Project Data Managers, and Clinical and Regulatory staff associates supporting clinical projects.
Plans and establishes programs for data transfers, edit check listings, data review listings and for QC and validation.
Oversees documentation and ensures consistent maintenance of code, logs and output within a regulated environment.
Work in IRT system from Specifications Review to doing UAT activities in IRT

Requires:
Bachelor’s degree in Statistics, Biotechnology, Pharmaceutical Science or closely related and 7 years of industry experience in Data Management as Clinical Data Manager, Quality specialist or Clinical Programmer.
Foreign equivalent degree acceptable.
Also requires at least 2 years of experience in the following (which may have been obtained concurrently): Oracle Inform, JReview, Clinical SAS, clinical research, GCPs, and DM processes, SDTM mapping, PK/PD.
Source: Job Diva – Job Listing

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