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    Clinical Project Manager - Slough, Berkshire, United Kingdom - MSI Pharma

    MSI Pharma
    MSI Pharma Slough, Berkshire, United Kingdom

    Found in: Jooble UK O C2 - 2 days ago

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    Description

    MSI Pharma are looking for a Clinical Project Manager to join a prestigious Biotechnology company based in the UK accountable for leading Clinical Study Teams across Phase 1 studies.

    At the study kick-off meeting, articulate study scope, goals, and expectations of the business to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.

    Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings.

    Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit.

    Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.

    Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.

    Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.

    Bachelor's degree or equivalent required (scientific or healthcare discipline preferred).
    ~ideally 3+ years clinical project management experience including leading and managing cross functional teams
    ~ Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.

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