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QC Specialist

1 month, 2 weeks ago
India
Full-time
Mid Level
Manual QA Tester
Quality Assurance and Testing
Oracle SQL Server
Apply Now
eClinical Solutions

eClinical Solutions

eClinical Solutions is a leading provider of clinical data management solutions, offering software and services that enable organizations to maximize the value of their clinical data. Their elluminate platform empowers users with complete access to sta...

Professional Services
251-1K
Founded 2006
View All Jobs 10

Description

  • Perform quality control activities, including documentation review and testing, for Biometrics client deliverables.
  • Review Rave EDC and data management outputs such as eCRFs, data validation specifications, custom functions, data extracts, data integrations, data mapping, reports, and listings.
  • Participate in the design and development of quality control procedures.
  • Manage documentation created during the quality control process.
  • Liaise with study teams and other staff to support project execution.
  • Develop and lead training and knowledge transfer activities for the quality control team.
  • Inform management of training issues, project activities, quality concerns, and timeline risks.
  • Collaborate with the project team to ensure deliverables are completed on time and at high quality.
  • Perform other assigned duties as needed.

Requirements

  • Four-year college degree or higher preferred, ideally in a scientific or analytical discipline such as Computer Science or a health-related field.
  • Excellent command of English.
  • Minimum 3-5 years of experience in the pharmaceutical or biotechnology industry, or equivalent.
  • Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities, and industry standards such as CDASH and SDTM preferred.
  • Experience performing quality control activities for clinical trial deliverables preferred.
  • Excellent verbal and written communication skills.
  • Strong attention to detail with the ability to multitask, prioritize, plan, and stay organized.
  • Strong team player.
  • Extensive knowledge of Medidata Rave EDC and other Rave modules preferred.
  • Familiarity with databases such as SQL Server and Oracle highly preferred.
  • Extensive validation experience with eCRFs, edit checks, custom functions, and data management reports.
  • Good understanding of database structures and programming languages.
  • Proficiency in Microsoft Office applications, especially Word, Excel, and PowerPoint.

Interested in this position?

Apply directly on the company website

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