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    Clinical Solution Analyst - Raleigh, United States - Integrated Resources, Inc

    Integrated Resources, Inc
    Integrated Resources, Inc Raleigh, United States

    1 week ago

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    Description

    Please note:
    in line with
    policy, this role is VDI only. will not be providing a laptop or equipment.


    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 Ourcome 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 *** s 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.
    Ensures delivery of clinical solutions to collect and manage data in studies.
    Works with external stakeholders (e.g., Clinical Research Organization (CRO)) and
    clinical teams to ensure successful implementation and maintenance of solutions for
    data collection and management within studies.
    Provide operational data reporting and data discovery dashboards for review and
    analysis to support Clinical Teams on identifying data related issues, review
    study/program metrics, and provide an overview of cross-projects/trials analyses for
    various functions including Patient Safety, Patient Value Units and senior management
    as required.
    Provide skilled business advice on the selection of new clinical technologies in line with
    *** s strategy by evaluating new technologies and their potential use while assessing
    the business risks and benefits.
    Participate and may lead workstreams/taskforces to define the usage of clinical
    applications and business processes to achieve efficiencies and synergies in system
    support, eliminating redundancies and streamlining activities.
    Responsible for training the Super Users/Advocates to be experts and knowledgeable
    in clinical applications and have oversight of their support. Manages and leads the
    User Group/Stakeholders meetings and discussions ensuring alignment across
    departments.
    Provide training, mentoring, and guidance to new team members as needed.
    Support audits and inspections as required and other responsibilities and projects that
    the Company may assign.
    Specific skills
    Strong computer proficiency, especially in use and management of databases and
    generating reports.
    Ability to work cross-culturally and provide skilled leadership/guidance to teams
    located worldwide.
    Advanced written and verbal communication skills. Strong communication skills with
    all levels of personnel globally, interpersonal skills and the tact and discretion required
    for negotiation within a global team setting to obtain cooperation and approval from
    other team members. Must be able to effectively organize ideas for logical
    presentation and acceptance.
    Experience in leading and participating in collaborative work teams at local and global
    levels.
    Experience in managing multiple tasks, projects and personnel concurrently.
    Self-motivating with the ability to work without supervision.
    Project management skills.
    Proficiency in English.
    Good organizational skills, problem solving skills, and supervisory skills.
    Ability to engage and motivate application users.
    Experience in engaging key stakeholders and customers to influence and achieve
    optimal business objectives and to promote strategic initiatives.
    Problem solving
    Proactive problem solver, uses initiative, identifies problems and/or opportunities for
    improvement and proposes workable and acceptable solutions.
    High levels of initiative, drive and commitment with an ability to adopt an
    entrepreneurial and innovative style when required.
    Open minded, with ability to understand conflicting issues and priorities, and negotiate
    acceptable resolutions, across functions.
    Able to adapt to change and champion the change.
    Able to plan, perform, trouble-shoot and make decisions based on precedent, company
    policies, *** procedures, international and national regulations and Good Clinical
    Practice (GCP)
    Ability to work accurately and efficiently and when necessary create new processes and
    procedures.
    Experience in evaluating system reports and Service Level Agreement (SLA) reports to
    detect potential problematic issues.
    Ability to manage uncertainty.
    Must be creative and develop cost-effective solutions in an effort to maximize
    efficiency and achieve success when confronted with limited resources.
    Experience Without, at
    least, a
    Bachelor s
    degree
    With, at least, a
    Bachelor s
    degree
    Pharmaceutical/CRO setting. 9+ years 7+ years
    Relevant experience in the clinical data / technology field in Drug
    Development or Life Sciences working with EDC, CTMS, TMF, MDR,
    CDR, COAR, BI reporting/dashboards, system integrations, and other
    systems.
    7+ years 5+ years
    Good Practice (GxP) and system validation experience. 7+ years 5+ years
    Knowledge of clinical processes and technical framework.
    Previous experience creating new processes, Standard Operating Procedures (SOPs) and related
    documents.
    Knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management
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