Jobs

    Accounts Team Leader - Canada - ICON Strategic Solutions

    ICON Strategic Solutions
    ICON Strategic Solutions Canada

    2 weeks ago

    Default job background
    Description

    As a Global Trial Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

    The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements.

    The GTL is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document (PED) to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.

    The GTL is responsible for leading the cross-functional Trial Team (including GCDO and non-GCDO members) and interfaces with all trial team members, building the trial operational plan, is responsible for ESP contracts and budget, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team (CT)'s objectives.

    The GTL provides global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof.

    The GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Responsible Physician.

    This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.

    Tracking of Project Deliverables & Timelines using Functional Planning tools and support. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
    Accountable for delivery of global trials within agreed/projected life of trial budget.

    Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.

    Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.

    Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within timelines. Is accountable for oversight of all external service providers used for the trial for both in-house and outsourced studies.

    For outsourced trials is responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO.

    Is primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
    Collaborate with Quality Management & Compliance liaisons to ensure quality oversight of assigned trial utilizing the available tools.

    Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Responsible Physician (SRP), the GTL ensures appropriate trial-specific training is given to Trial Team members or to the CRO.

    Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they can not be resolved within the function and/or Trial Team they are escalated to the GCDO Program Leader (GPL) and Clinical Team level, as necessary.

    Manages timely and accurate documentation of issue escalation.

    Strong interaction with the Therapeutic Area, other GCDO functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome.

    Requires clinical research operational knowledge, project planning/management, communication and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experience managing or leading global or regional teams in a virtual environment is required. Strong expertise in vendor management required.
    To qualify, applicants must be legally authorized to work in the Canada or US, and should not require, now or in the future, sponsorship for employment visa status
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