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Clinical Data Integrity Specialist

Clinical Data Integrity Specialist

Tigermed India (Tigermed Clinical Research India Pvt Ltd)Republic Of India, IN
11 days ago
Job description

Clinical Data Validation Specialist - Elluminate experience

Location : Bangalore / Mumbai / Remote (WFH)

Experience : 2+ years

Job Responsibilities :

  • Develop and implement data cleaning and reporting solutions to ensure quality and timely delivery of study data, metrics, and visualizations as per data review plans.
  • Create and maintain documentation for all reporting deliverables throughout the study lifecycle.
  • Build a library of reusable data checks in collaboration with data engineers and configuration specialists.
  • Partner with cross-functional teams to define business rules and establish an automated check library across therapeutic areas.
  • Ensure compliance with SOPs and work practices.
  • Act as a technical resource in developing data analytics for data validation and cleaning.
  • Support knowledge sharing and training on reporting tools to ensure data accuracy and integrity.
  • Provide programming expertise to enhance data quality and create tools, macros, and libraries for efficient data review.
  • Develop and test data review listings and maintain operational excellence through collaboration with clinical data management and medical reviewers.
  • Drive innovation and process improvement in reporting and data management practices.

Core Strength :

  • Bachelor’s degree in computer science, Statistics, Biostatistics, Mathematics, Biology, or a related health field, or equivalent experience.
  • Good understanding of the drug development process and regulatory data standards (CDISC, SDTM preferred).
  • Minimum 2 plus years of experience in developing programming listings and visualizations using tools such as Veeva CDB, JReview, or Elluminate ( Elluminate experience preferred).
  • Proficient in programming languages such as CQL, SQL, SAS, R, or Python.
  • Familiar with clinical database systems (e.G., Metadata Rave, Veeva, InForm).
  • Skilled in using Microsoft Office tools (Word, Excel, Outlook).
  • Strong understanding of clinical trial terminology.
  • Able to work independently in a fast-paced environment, demonstrating initiative and adherence to deadlines.
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    Clinical Data Specialist • Republic Of India, IN

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