Skip to main content
Caidya

Clinical Project Manager

1w

Caidya

Shanghai, CN · Full-time · CNY 400,000 – CNY 700,000

About this role

The Clinical Project Manager oversees clinical trials insourced to a global MNC, ensuring accountability for study timelines, budgets, and quality targets. This role builds and manages clinical trial budgets while delivering Best In Class metrics. It serves as the authoritative source for study information and status reporting.

Day-to-day involves leading the China core study team, facilitating meetings with agendas, minutes, action logs, and decision logs. The manager ensures adequate resources, fosters team health through assessments, and promotes cross-functional communications. Operational metrics are monitored, trends managed, and escalations handled effectively.

In this team environment, the role leads study risk planning like IQMP, work orders, change orders, and resolution of Significant Quality Events. Comprehensive input is provided to protocol design, with maintenance of SOP logs and remediation of quality metrics. Inspection readiness and Quality Gate planning are key responsibilities.

Growth opportunities include leading preparations for operational governance, obtaining approvals, and presenting studies with timelines, costs, and risks. The position drives effective decision-making and team chartering for efficiency. It emphasizes proactive management of study health and governance expectations.

Requirements

  • Experience in clinical trial project management
  • Knowledge of clinical operations in China
  • Proficiency in study risk management and IQMP processes
  • Familiarity with clinical trial budgeting and forecasting
  • Background in cross-functional team leadership
  • Understanding of GCP and regulatory compliance in pharma
  • Skills in operational governance and quality metrics remediation

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 core study team meetings
  • Ensure adequate China study team resources and effective team structure
  • Oversee the study risk planning process (e.g., IQMP)
  • Monitor operational metrics across the study and manage escalations
  • Lead study work order and change order processes
  • Ensure inspection readiness and Quality Gate timing planning