- 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 (e.g. meeting agendas & 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 (e.g. 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. Participate and may present assigned study (ies) in part or in full to technical and executive governance.
If taking on program level work in addition to study level work, additional responsibilities include: - Represent clinical operations on the asset level teams as per the organizational expectations and asset team charter, serve as a single point of accountability for operational delivery of clinical programs in China - Lead clinical operations' sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations and asset team charter - Define optimal operational strategy and define timeline, resourcing and budget needs for execution of the clinical plan for the asset/program including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for the licensing and partnership opportunities - Establish and ensure adherence to operational standards and best practices for the asset or program - Lead the Operations Strategy including the Clinical Operations Plan along with the Sourcing/Vendor Strategy - Manage and deliver to timelines, budget and quality for all studies in a program - Interface with the China Study Lead and program level roles including at the CRO - Participate in program level feasibility & country strategy - Attend and represent Clinical Operations at governance meetings (including co-development studies) - Manage & support escalations - Inspection management & readiness - Monitor progress against plan; develop and implement formal operational risk management plans across the asset/program
Minimal/Must-have Requirement
- Extensive clinical trial conduct, clinical trial operations, and a thorough understanding of the processes associated with project and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations - BS +8 years relevant experience - MS/PhD + 7 years’ relevant experience - Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise) - Demonstrated project management / leadership experience - Experience in understanding of key drivers impacting budgets - Experience in building a Clinical Trial Budget and managing project to budget
