Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Leads or supports cross-functional trial teams, including vendors. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
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The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities.
$106,500–$202,500
USD/year
This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences, and includes aligning DSS study teams with program- and study-level strategies. For assigned programs and studies, the role leads the DSS Study Team and represents DS as a member of the cross-functional study team. The role also utilizes operational analytics and project management tools to optimize execution of programs and studies.