Global Study Manager

Global Study Manager - Oncology and/or Multi TA

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

What You Will Do:

You will manage day-to-day project and program management activities, supporting your team to deliver quality outcomes.

Key responsibilities include:

• Responsible to form, oversee and lead the operational sub team and request resources as needed

• Accountable for the development of realistic detailed study startup and/or study management strategy and monitoring plans, including Sourcing Strategy, input into Requests for Proposals, and for the selection of vendors

• Accountable for ensuring country-level feasibility is completed in collaboration with cross functional GSSO colleagues and Operational Analytics & Quantitative Sciences (OAQS) organization and pCRO (as applicable) reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans

• Accountable and responsible to ensure PTMF setup for Study management and Country/Site level documents

•  Inputs into the IQMP risk planning process for the study

• Coordinates development of study/protocol training & global investigator meetings. 

• Accountable to ensure local Investigator meetings are coordinated by the Study Operational Manager (if assigned to study) and as applicable

• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)

• Accountable to ensure Study Operational Managers are inputting into the budget for local/country level tasks (if assigned).  The Global Study Manager will ensure cost variance, invoices, POs, etc. are reviewed in a timely manner ensuring spend is appropriate and on track with the forecast.

• Responsible for monitoring the budget and contracts for assigned vendors (e.g., central labs, ePRO, radiology, pCRO, etc.).

• Accountable for the delivery of the study against approved plans

• Leads inspection readiness activities related to study management and site readiness

• Support development and delivery of decentralized capabilities at investigator sites 

• The Global Study Manager if assigned to study post database lock will ensure timely study closure and release of internal and external resources as appropriate.

• Development, review or approval of the Study Startup, Study Monitoring & protocol recruitment plans and others (e.g., CRF Guidelines, IMPALA manual, Training Plan, etc.) The Global Study Manager can delegate development of plans or components of plans to Study Operational  Managers (if assigned) or CSTAs as appropriate.

• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Interactive Randomization Systems with Supply Chain Lead

• Accountable to ensure overall vendor oversight for vendors managed by Study Operational Managers (if assigned), action escalations related to vendor issues and escalate further as necessary

• Reviews consolidated Pre-trial Assessment reports, feasibility outputs, etc. in partnership with appropriate cross functional colleagues

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