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    Clinical Solutions Analyst - Raleigh, United States - Advanced Recruiting Partners

    Advanced Recruiting Partners
    Advanced Recruiting Partners Raleigh, United States

    Found in: Appcast US C2 - 1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Primary Purpose / Regulatory Responsibilities:

    A primary function of this position is to globally provide skilled Key User oversight of clinical

    applications and data repositories, including system upgrades and change requests to be

    implemented on timely manner and within budget.

    The further key function of this position is to lead the implementation of data collection and

    management solutions for clinical studies, ensuring appropriate requirements gathering, specification, selection and implementation.

    Responsible for the oversight and management of Key User support for clinical

    applications, system integrations, and data repositories.

    Systems may include:

    Clinical Trials Management System (CTMS); Business Intelligence (BI) and

    dashboards for CTMS; electronic Trial Master File (eTMF); Electronic Data

    Capture (EDC)/ Thesaurus Management System (TMS) and underlying systems;

    Clinical Outcome Assessment Repository (COAR); Metadata Repository (MDR);

    Clinical Data Repository (CDR); Electronic Document Management System

    (EDMS); and others

    Oversee system upgrades and change requests and work in collaboration with

    Information Technology (IT) in the System Development Life Cycle (SDLC) from

    feasibility, gathering requirements to implementation, training and maintenance

    Define the expected business outcomes that are supported by the application and any

    required integrations including expected service level agreements.

    Prioritize IT support, projects, change requests, and support the process of collection

    and consolidation of projects in line with Global Clinical Sciences and Operations

    (GCSO) and strategy with regards to IT project/budget planning.

    Act as delegate of the Process Data Owner (PDO) in the creation, review, and approval

    of system documentation.

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