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.
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.
Requirements
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.
Required Skills:
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.
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 planni...
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.
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.
Requirements
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.
Required Skills:
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.
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