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    Clinical Trial Manager - United Kingdom - IQVIA LLC

    IQVIA LLC
    IQVIA LLC United Kingdom

    1 week ago

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    Description

    IQVIA's cFSP (sponsor-dedicated) team are seeking a Clinical Trial Manager to join us on our mission to drive healthcare forward.

    The Clinical Trial Manager will partner with the Clinical Trial Assistants, Clinical Research Associates, Central Trial Managers and Global Trial Managers to ensure overall study delivery at country level.

    RESPONSIBILITIES

    Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. (Accountable for study deliverables and drives key decisions within set country)

    Plan, manage, and maintain oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)

    Support country-level operational planning and accountable for site selection within assigned country(ies)

    Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.

    Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)

    Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training

    Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning

    Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process

    Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:

    Monitor and review country and study trends Review Monitoring Visit Reports

    Identify and facilitate resolution of cross-functional study-specific issues

    Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)

    Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships

    REQUIRED EDUCATION AND EXPERIENCE

    Bachelor's degree in a healthcare or other scientific discipline

    Minimum 1-2 years' experience of leading local/regional or global teams

    Minimum 1-2 years' clinical trial project management experience

    Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).

    REQUIRED KNOWLEDGE

    Local knowledge / expertise of regulatory environment, study start up process and associated timelines etc.

    Clinical trial processes and operations

    Extensive knowledge of ICH/GCP regulations and guidelines

    Project and Program management including oversight of study deliverable, budgets and timelines

    Time, cost and quality metrics, Key performance indicators (KPIs)

    #LI-AdamThompson

    IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

    About Us

    IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us. #J-18808-Ljbffr
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