Accountable for managing overall study timelines, budgets and quality targets.
Accountable for building, forecasting and managing the Clinical Trial Budget. Leads the China core study team; manages, facilitates and documents core study team meetings, for example meeting agendas and minutes, action logs and decision logs, and facilitates effective decision making. Ensures adequate China study team resources and leads study team chartering to ensure that study team structure, including sub-teams, are effective and efficient. Fosters optimal China study team health including formal team effectiveness assessments and action planning. Manages China study team communications to ensure cross-functional connectivity among study team members and supporting functional lines. Leads and oversees the study risk planning process, for example IQMP. Oversees operational metrics across study and manages trends and escalations. Accountable for delivery to Best-in-Class metrics. Acts as a single, authoritative source of the study information and leads study level status reporting per organizational norms and expectations. Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log. Leads awareness and resolution of Significant Quality Events (SQEs) and escalations. Leads the study work order and change order processes. Ensures comprehensive operational input to protocol design. Monitors and remediates quality metrics and completes remediation tracker. Responsible for inspection readiness. Ensures Quality Gate timing planning and team readiness. Responsible for obtaining requisite operational governance approvals per organizational norms and expectations. Leads preparations and presents the study to operational governance. Provides clinical timelines, cost, and operational risk sections of the governance presentations, memos, and other materials used for decision making. Participates and may present assigned study(ies) in part or in full to technical and executive governance.