About this role
The Clinical Project Manager is accountable for managing overall study timelines, budgets, and quality targets in pharmaceutical clinical trials. This role leads the China core study team, facilitating effective decision-making through structured meetings, agendas, minutes, and action logs. Ensures delivery to Best In Class metrics across the study.
Day-to-day responsibilities include building and forecasting the Clinical Trial Budget, overseeing operational metrics, and managing trends with escalations. Leads study risk planning processes like IQMP, ensures protocol design input, and monitors quality metrics with remediation trackers. Handles study work orders, change orders, and maintenance of SOP logs.
In the team environment, fosters optimal China study team health via formal assessments and action planning. Manages communications for cross-functional connectivity and ensures adequate resources through study team chartering. Acts as the authoritative source for study information and status reporting per organizational norms.
Growth opportunities include leading preparations for operational governance approvals and presenting studies to governance bodies. Provides clinical timelines, costs, and risks for decision-making materials. For program-level expansion, represents clinical operations on asset teams, defines strategies, and manages multiple studies' delivery.
Requirements
- Extensive clinical trial conduct experience
- Clinical trial operations expertise
- Thorough understanding of processes associated with project and study management
- Experience leading cross-functional study teams in China
- Proficiency in clinical trial budget forecasting and management
- Knowledge of study risk planning and quality metrics remediation
- Familiarity with operational governance and inspection readiness in pharma
Responsibilities
- Manage overall study timelines, budgets and quality targets
- Build, forecast and manage the Clinical Trial Budget
- Lead the China core study team and facilitate meetings with agendas, minutes, action logs and decision logs
- Oversee study risk planning process (e.g. IQMP) and operational metrics
- Ensure inspection readiness, Quality Gate planning and operational governance approvals
- Lead awareness and resolution of Significant Quality Events (SQEs) and escalations
- Provide operational input to protocol design and manage study work order processes
- Act as single authoritative source for study information and status reporting
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