Clinical Data Validation Specialist

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.