Validation Analyst

Tata Consultancy Services; Mumbai; On-site; INR 1,000,000 - 1,600,000; Full time

Job summary

Tata Consultancy Services is seeking an experienced Data Management Programmer to create data cleaning reporting solutions, validate data integrity, and support study data with advanced analytics. You will develop reusable checks with data engineers, document reports, and enhance reporting tools for cross-functional use.

The role requires expertise in SAS, Python, SQL, R, and visualization tools, with strong communication and project management skills.

Qualifications

• Ability to create data cleaning reporting solutions with oversight
• Create documentation for reports across study lifecycles
• Develop reusable checks with data engineers and config specialists
• Collaborate across TAU to define business rules and automated checks
• Provide analytics for data validation and cleaning
• Support knowledge development on reporting tools and data integrity
• Develop macros and automated listings for department workflows
• Test listings and CRF/Query metrics generation
• Ensure data review reports align with data management standards
• Support development of data management programming talent base
• Setup analytics for coding reports, safety review, risk-based monitoring
• Experience with regulatory data standards; CDISC knowledge preferable
• Strong leadership, decision-making, negotiation and PM skills
• Experience with relational databases like SQL Server/Redshift/Oracle
• EDC build and clinical data management experience preferred
• Experience with AWS preferred
• Knowledge of data lake and interactive dashboards is preferred
• Proficiency in MS Office tools and programming in SAS, Python, SQL, R and visualization tools

Responsibilities

• Create data cleaning reporting solutions with oversight to support data quality and study status metrics
• Document reports throughout the study lifespan and asset
• Develop library of reusable checks with data engineers
• Collaborate across TAU to create business rules and automated checks
• Serve as technical resource for data analytics to support data validation and cleaning
• Support knowledge development on reporting tools and data integrity
• Provide programming expertise for data cleaning to ensure high-quality data
• Enhance reporting tools/macros/libraries for cross-functional use and set data management standards
• Create macros for standard listings and test data review listings
• Develop programs to generate CRF and Query metrics including ad-hoc requests
• Ensure operational excellence with partners for standards application and data cleaning reports
• Directly support knowledge development on data reporting tools
• Develop innovative concepts to improve processes
• Identify development opportunities within the team
• Support development of Data Management Programming talent base
• Set up and configure analytics for coding reports, safety review, and risk-based monitoring
• Leverage experience in clinical data management and data operations for reporting
• Understand regulatory requirements; CDISC knowledge preferable
• Communicate effectively with stakeholders and manage projects
• Demonstrate experience managing complex projects and partnerships
• Utilize databases like MS SQL Server, Redshift, or Oracle
• EDC build and clinical data management experience preferred
• AWS experience preferred
• Automate data validation and implement data lake dashboards
• Proficient in Microsoft Office and visualization tools

Skills

Data cleaning

Data validation

Reporting & dashboards

Cross-functional collaboration

Project management

Leadership

Communication

Tools

SAS

Python

SQL

R

Tableau

Spotfire

Boxi/JReview

Plotly

RShiny

MS SQL Server

Redshift

Oracle

AWS

Job description

Responsibilities:

• Create data cleaning reporting solutions with appropriate oversight that support the quality and timely delivery of data cleaning, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans.


• Create any documentation needed for reports throughout the lifespan of the study and/or asset for all deliverables


• Develop library of reusable checks working closely with data engineers and config specialists.


• Collaborate with cross functional teams in creating business rules and automated check library across TAU.


• Serves as a technical resource for creating data analytics to help with data validation and cleaning


• Supports knowledge development of others on reporting tools that support the accuracy and integrity of study data


• Provide programming expertise for data cleaning to efficiently ensure high quality data


• Enhances available reporting tools/macros/libraries or creates new ones to support the review of clinical trial data and trial status information for cross-functional use and provides input on data management reporting standards as required


• Ensure accurate delivery by creating macros for Standard listings for the department based on specifications.


• Creates and tests listings for data review.


• Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests.


• Ensures operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Management and medical reviewers


• Directly supports knowledge development of others on data reporting and reporting tools that support the accuracy and integrity of study data


• Develops innovative, advanced new concepts that improve processes


• Recognizes development needs and identifies/creates development opportunities within team


• Supports the development of the Data Management Programming talent base and identifies development needs within the area of responsibility


• Ability to setup and configure analytics for coding reports, safety review and any risk-based monitoring activities


• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.)


• Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable


• Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills


• Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas


• Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle),


• EDC build and/or clinical data management experience preferred


• Experience in AWS preferred


• Experience setting up automated validation is preferred


• Knowledge of Data lake and creating interactive Dashboards are preferred


• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)


• Programming, specifically SAS , Python, SQL, and R, and other visualization tools hands-on experience (BOXI, Spotfire, Tableau, RShiny, JReview, Plotly, Elluminate)