Manager, Site Start Up

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Job Description

The Clinical Study Startup, Manager oversees and manages the initiation phase of clinical studies. You will ensure that all startup activities are completed efficiently and in compliance with regulatory requirements, contributing to the successful execution of clinical trials.

Objective / Purpose:

• The site start up manager defines, develops and delivers the global site start up plan.

• Oversee the analysis of clinical trial data and its application to conduct accurate study start up forecasts.

• Drive rapid, accurate, and data-driven study start up forecasts, benchmarking assumptions, scenarios and accurate planning.

• Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Site Start Up Services.

Accountabilities:

• Establish, develop and deliver the Global Site Start Up Plan.

• Partner with Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes.

• Provide guidance, oversight, and training to the Site Start Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study start up, country and site selection, study start up planning, and modeling.

• Ensure standards are applied to the study start up process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.

• Guide the collection and analysis of all data to influence site start up timelines.

• Leverage leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with site initiation timeline forecasting.

• Agree to deliverables on a site-level basis with the SSU team and monitor adherence to these. Promptly recognize and improve potential delays and escalate non-performance.

• Lead the site start up team, using the appropriate team members to help implement the Site Start Up Plan.

• Drive delivery of all Takeda and CRO supported sites that are "Ready To Enroll"

• Resolve escalated issues identified by the site start up team in partnership with the Study Manager

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