Responsibilities: Lead the ONC US Site Management and Monitoring Study Start-Up team to execute the delivery of site start-up activities for oncology studies.Develop and deploy cross-functional collaboration and coordination of the Study Start-Up Managers team resources to ensure optimal resource utilization and drive best-in-class activation delivery focused on quality, efficiency, and expediency.Embed consistent ways of working across the Study Start-Up group and build group capabilities.Leadership of the SSU manager group, building team spirit and developing team style and behavior.Assign skilled SSU managers to studies and sites.Provide oversight to SSU managers to ensure quality and timely site start-up activities in accordance with study timelines and clinical performance targets.Develop and implement efficiency measures in the activation process.Conduct routine reviews of activation output to identify challenges and best practices.Create a cross-functional environment of best practice sharing and implement process changes when applicable.Define SSU strategy and provide direction to SSU managers on study commitments.Ensure collaboration across US ONC SMM stakeholders including LSAD, contract managers, feasibility lead, site engagement lead, and clinical research associates.Provide regular information and reports to manager and US ONC SMM leadership team on study start-up status and risk mitigation.Work with Directors within US SM&M to support capacity management, achieve accurate resource forecasting, analysis, and solution building.Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building, and issue resolution.Ensure that the workload of the team(s) or direct reports is adequate.Oversee the development and performance management of the team(s) or direct reports.Ensure that everyone on the team or direct reports has development and training plans, according to IDP process.Ensure training plans/trainings are completed via SABA within required 30-day certification timelines.Ensure that the individual performance planning and review process is completed for all direct reports.Prepare salary and bonus proposals for all team members or direct reports based on their performance in close collaboration with responsible Director SMM and HR partner.Ensure all systems are continuously updated and filing of SSU documents.Oversee support systems and personnel (vendors) managing processes.Contribute to the quality improvement of study processes and other procedures.Plan and organize coaching of the team members and all direct reports.Act as first-line support for GCP and AZ processes.
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