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IT Analyst, Electronic Submissions - United States  

Charles River (company)

Posted on : 13 August 2017

Project Description



Perform systems analysis and requirements gathering for large and small scale system implementations within regulated and/or non-regulated IT environments.  Create electronic data specifications for sponsors.


  • Validate software for electronic submissions, which includes requirements gathering, test script writing, test script execution and other validation tasks.
  • Perform review and appraisals of computer hardware, software and associated products for electronic submissions.
  • Ensure work is compliant with applicable guidelines and regulations (e.g., SOP, GLP, PLC, MVP, etc.).
  • Provide software training and support as required to end users and computer department staff.
  • Assist users, with to identifying and resolving software issues.
  • Provide support to users for data capture for electronic submission compliance.
  • Manage standardized glossaries in Centrus and co-ordinate with all other collection system glossaries administrators.
  • Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports in order to compare them with the electronic data and ensure the data is accurate.
  • Create SEND datasets for electronic submissions and piloting purposes.
  • Assist with global system control change for electronic submissions compliance.
  • Create and maintain user’s templates and implement Provantis Import module for non-Provantis/manual data.
  • Ensure issues are identified, tracked, reported on and resolved in a timely manner.
  • Consistently deliver high-quality services to customers and manage customer expectations effectively.
  • Communicate effectively with customers to identify needs and evaluate alternative business solutions with project management.
  • Lead internal teams/task forces as needed.
  •  Perform all other related duties as assigned.

  • Education: Bachelor’s degree (B.A. /B.S.) or equivalent in Computer Science or related discipline.
  • Experience: One to two years related experience.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: None
  • Other: Knowledge of current IT technologies.  Possess an overall understanding of safety assessment data as well as a general understanding of CDISC Standards.  Knowledge of MS Excel required. Requires excellent communication and interpersonal skills.  Requires great attention to detail. Ability to work well in a team environment.

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet