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    Veeva Vault Clinical Specialist - Bengaluru, India - Data Paths

    Data Paths
    Data Paths Bengaluru, India

    3 weeks ago

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    Description

    5 years of experience working with Veeva Vault Clinical trial management systems in the pharmaceutical or biotech industry.

    Lead the implementation and configuration of Veeva Vault Clinical applications to meet business requirements and industry standards.

    Customize Veeva Vault functionality, including study setup, electronic trial master file (eTMF) management, and regulatory document tracking.

    Provide end-user training and support on Veeva Vault Clinical applications, including best practices for data entry, document management, and workflow automation.

    Serve as a subject matter expert on Veeva Vault functionality and capabilities, assisting users with troubleshooting and issue resolution.

    Data Management and Reporting:

    Oversee the management of clinical trial data within Veeva Vault, ensuring data integrity, accuracy, and compliance with regulatory requirements.

    Develop custom reports and dashboards to provide insights into clinical trial progress, data quality, and compliance metrics.

    Ensure that Veeva Vault Clinical applications are configured and maintained in compliance with regulatory requirements, including FDA guidelines and ICH-GCP standards.

    Support regulatory inspections and audits by providing documentation and evidence of system validation and compliance.

    Collaborate with IT and system administrators to integrate Veeva Vault Clinical with other clinical

    systems and applications, ensuring seamless data exchange and interoperability.

    Perform system maintenance activities, including software upgrades, patches, and enhancements, to

    optimize system performance and reliability.

    In-depth knowledge of clinical trial processes, including study startup, site activation, patient enrollment, and data management.

    Strong understanding of regulatory requirements for clinical trials, including FDA regulations, ICH-GCP guidelines, and EMA directives.

    Experience in system implementation and configuration, including study design, form creation, and workflow development.

    Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

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