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Dinan

    System Analyst - McLean, United States - Econosoft Inc.

    Econosoft Inc.
    Econosoft Inc. McLean, United States

    3 weeks ago

    Default job background
    Description
    Bachelor's degree preferred or commensurate with experience
    3+ years experience in pharmaceutical, project administration and/or administrative role.
    Experience with clinical operations technologies desired (e.g. Veeva)
    Understanding of system development lifecycle requirements and US CFR/ICH GCP
    Knowledge of data stewardship principles and methodologies such as data quality, data governance and/or master data management
    Experience with Microsoft Office (Excel, Word, PowerPoint, Outlook, TEAMS)
    Strong written/verbal communication skills and project management skills
    Demonstrated ability to work well within a matrixed environment, and an ability to build solid relationships / make connections across the organization
    Ability to manage and provision large datasets with a high degree of performance and trust
    OBJECTIVES/PURPOSE

    (3-4 bullets)
    Manage required business administration tasks and responsibilities in relation to Operational Data Systems
    Troubleshoot system issues; Work closely with business system lead to identify and track business needs and opportunities for future system upgrades
    Lead and manage user access request forms including verification of training and access approval for Operational Data Systems

    Manage and produce high quality end user central support model processes and materials, including but not limited to system procedures, guidances, tools, and forms.

    Troubleshoot system issues and help define enhancements; Work closely with business system lead/SME to identify and track business needs and opportunities for future system upgrades
    Responsible for fulfilling required business administration tasks and responsibilities in relation to Operational Data Systems including; centralized Inbox management, Global directory management, Study Creation, Loader sheet creation and support, and other data creation requests
    Responsible for managing user access request forms including verification of training and access approval for Operational Data Systems; Work with key stakeholders to coordinate auditor/inspector access (as needed)
    Lead and participate in the development and delivery of end-user training, access and central support model for GDO managed operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.)
    In collaboration with key stakeholders, support data and documentation requests for audits, regulatory inspections and/or other internal purposes
    Liaise with IT Technology Leads and Business Stakeholders to resolve system issues and help define enhancements; Work closely business teams, identify and track business needs and opportunities for future system upgrades
    Manage framework for assessing tracking and managing end user compliance with operational system standards
    Other
    May deliver educational training in relation to operational data systems
    May serve and/or support SMEs as a key point of contact for operational data systems including liaising with key stakeholders and impacted functional areas within R&D
    Seek opportunities to actively participate in process optimization initiatives; Provide input and identify opportunities to leverage operational data and/or technology to further optimize in support of an outsourced trial operating model including considerations for oversight requirements, predictable trial delivery and industry best practices
    Assist in data stewardship for GCO and I&D managed operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical)

    Other duties as assigned.

    EDUCATION,


    BEHAVIOURAL COMPETENCIES AND SKILLS:
    (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
    Bachelor's degree preferred or commensurate with experience
    3+ years experience in pharmaceutical, project administration and/or administrative role.
    Experience with clinical operations technologies desired (e.g. Veeva)
    Understanding of system development lifecycle requirements and US CFR/ICH GCP
    Knowledge of data stewardship principles and methodologies such as data quality, data governance and/or master data management
    Experience with Microsoft Office (Excel, Word, PowerPoint, Outlook, TEAMS)
    Strong written/verbal communication skills and project management skills
    Demonstrated ability to work well within a matrixed environment, and an ability to build solid relationships / make connections across the organization
    Ability to manage and provision large datasets with a high degree of performance and trust

    ADDITIONAL INFORMATION
    (Add any information legally required for your country here)
    Ability to work with wide range of global stakeholders
    Strong adaptive communication skills across multiple levels of the organization
    Excellent written, verbal and project planning skills
    Inspire, motivate and drive results
    Seek input from multiple constituents and stakeholders to drive innovative solutions
    Incorporate feedback and ensure decisions are implemented swiftly
    Negotiate and resolve conflicts in a constructive manner
    Build strong relationships and collaborate effectively with other interfacing Takeda functions
    Self-starter with demonstrated success working independently.
    Self-motivated with comfort working on high performance teams.
    Tolerance of ambiguity and willingness to work through complex issues
    Ability to work with global internal and external partners to achieve desired goals
    Ability to develop solutions to complex issues and challenges
    Promotes team work while working through solutions
    Address
    #J-18808-Ljbffr
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