Experience Range | 10+ years |
Primary (Must have skills)* - To be Screened by TA Team | 4+ years managing Veeva CTMS and eTMF systems for configuration, user support, and compliance management.
4+ years ensuring data integrity and migration with focus on validation, cleanup, and accurate transfer across GxP-regulated systems.
4+ years leading project execution and management including planning, tracking deliverables, and resolving system/data-related issues.
4+ years supporting system validation and documentation aligned with 21 CFR Part 11 and CSA guidelines.
4+ years collaborating with cross-functional teams to improve system performance, ensure audit readiness, and maintain compliance. |
Job Description of Role* (RNR) - To be Evaluated by Technical Panel (Define it to give more clarity) | The Veeva CTMS/eTMF and Data Integrity Specialist will be responsible for managing system configurations, supporting end users, maintaining compliance, and ensuring data quality across clinical and regulatory systems. The role involves leading data migration and validation activities, overseeing project execution, and ensuring adherence to GxP, 21 CFR Part 11, and CSA guidelines. The candidate will work closely with business and IT stakeholders to support continuous improvement, audit readiness, and operational excellence. |
Soft skills/other skills - To be Evaluated by Hiring Manager (To define how this will be evaluated) | Communication Skills: Communicate effectively with internal and customer stakeholders (technical and non-technical )
Communication approach: verbal, emails and instant messages
Interpersonal Skills:
Strong interpersonal skills to build and maintain productive relationships with team members
Provide constructive feedback during reviews and be open to receiving the feedback.
Problem-Solving and Analytical Thinking: Capability to troubleshoot and resolve issues efficiently.
Analytical mindset
Task/ Work Updates
Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps
Provides regular updates, proactive and due diligent to carry out responsibilities |
Expected Outcome | 100% compliance with data integrity and system validation requirements.
Accurate and audit-ready documentation across CTMS/eTMF systems.
Seamless data migration and validation with minimal discrepancies
Improved system efficiency through proactive configuration and process improvements.
Successful project delivery within defined timelines and quality standards.
Enhanced user experience through timely support and training initiatives. |
Secondary Skills to be planned Post Hiring - Training Plan | Hands-on with HP ALM, Excel, and SQL for validation and reporting.
Familiarity with SaaS and Cloud-based systems (e.g., AWS, Veeva Vault).
Experience in documentation control and audit support.
Working knowledge of ETL or data mapping concepts. |