Clinical Data Validation Specialist

1 day ago

Mumbai, Maharashtra, India ApicalGo Consultancy Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Description:


- 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:


- Bachelors 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.

years of work experience with SQL

years of work experience with Databases

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