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CTMS Architect
3 months ago
Mandatory :
Key Responsibilities:
System Implementation and Configuration:
Lead the implementation of Veeva Vault CTMS, including system setup, configuration, and customization to meet organizational needs.
Collaborate with stakeholders to define requirements and ensure the system is tailored to support clinical trial processes.
System Management and Optimization:
Oversee daily operations of the Veeva CTMS, ensuring system performance, reliability, and data integrity.
Identify and implement improvements to optimize system functionality and enhance user experience.
Compliance and Data Integrity:
Ensure that the Veeva CTMS is compliant with regulatory requirements, including FDA, EMA, and ICH guidelines.
Implement and enforce data integrity practices to ensure the accuracy and security of clinical trial data.
User Training and Support:
Develop and deliver training programs for clinical trial staff on Veeva CTMS functionalities and best practices.
Provide ongoing support and troubleshooting to end-users, addressing issues and providing solutions as needed.
Project Management:
Manage projects related to Veeva CTMS, including upgrades, integrations, and system enhancements.
Coordinate with cross-functional teams, including IT, clinical operations, and data management, to ensure successful project execution.
System Integration:
Oversee the integration of Veeva CTMS with other systems and platforms, such as electronic data capture (EDC), clinical data management systems (CDMS), and regulatory systems.
Ensure seamless data flow and system interoperability to support clinical trial processes.
Reporting and Analytics:
Develop and generate reports and dashboards to provide insights into clinical trial performance and system usage.
Analyze data to identify trends, issues, and opportunities for improvement.
Documentation and Compliance:
Maintain comprehensive documentation of system configurations, processes, and procedures.
Ensure adherence to internal and external audit requirements and manage audit preparations.
Stakeholder Engagement:
Serve as the primary point of contact for Veeva CTMS-related queries and issues.
Engage with vendors, consultants, and external partners to ensure alignment and support for system needs.
Qualifications:
Education: Bachelor’s degree in Life Sciences, Information Technology, Computer Science, or a related field. Veeva certification is mandatory
Experience: Minimum12 years of experience managing or implementing clinical trial management systems, with a focus on Veeva Vault CTMS.
Skills:
In-depth knowledge of Veeva Vault CTMS functionalities, configuration, and best practices.
Strong understanding of clinical trial processes, regulations, and compliance requirements.
Excellent project management skills, with the ability to manage multiple projects and stakeholders.
Strong analytical and problem-solving abilities, with a focus on data integrity and system optimization.
Effective communication and training skills, with experience in supporting end-users and collaborating with cross-functional teams.
