Clinical Data System Architect

1 day ago

Delhi, Delhi, India beBeeClinicalDataSpecialist Full time US$ 12,00,000 - US$ 14,40,000

Job Title: Senior Clinical Data Systems Developer

Overview

This position requires an experienced clinical data systems developer to oversee the design, development, and maintenance of Electronic Data Capture (EDC) systems and associated clinical data modules.

  • Main Responsibilities:
  • The successful candidate will be responsible for end-to-end programming and configuration of EDC systems, including ePRO, RTSM, and other trial-specific modules.
  • Lead study database design, setup, testing, deployment, and maintenance throughout the clinical trial lifecycle.
  • Collaborate closely with data management and study teams to refine database specifications and configurations.
  • Develop and implement both standard and complex edit checks, including custom functions.
  • Conduct quality control and validation prior to key releases.
  • Create risk-based monitoring reports, including Key Risk Indicators (KRIs) and critical-to-quality metrics.
  • Generate protocol deviation reports based on EDC data and trend them over time.
  • Build ad-hoc data reports to support internal teams for ongoing data review and decision-making.
  • Data Analytics & Visualization:
  • Deliver graphical and visual analytical outputs using programming languages/tools.
  • Develop data status and trending reports including missing data, SDV status, queries, and review tracking.
Requirements
  • Bachelors degree in Computer Science, Life Sciences, or a related field.
  • Minimum 7 years of experience in database programming for clinical trials.
  • Certified in Medidata Rave (or equivalent EDC system).
  • Strong understanding of clinical trial data architecture and workflows.
  • Familiarity with clinical data standards.
  • Excellent attention to detail and ability to meet tight deadlines.
  • Strong verbal and written communication skills.
  • Ability to work independently as well as within cross-functional project teams.

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