Global Study Lead

About the role

AstraZeneca is hiring a Global Study Lead (GSL) in Beijing Yizhuang to lead and coordinate a cross-functional study team of experts. The GSL ensures clinical study progress meets timelines, budget and quality standards, and acts as the primary point of contact for outsourced studies with the CRO.

Key responsibilities

• Lead and coordinate the study team under the STOM RACI framework, and guide the core and extended team according to the study communication plan
• Act as the primary AZ contact for the CRO Project Manager on outsourced studies, keeping oversight documented throughout the study lifecycle
• Hold accountability for essential study documents from Clinical Study Protocol (CSP) to Clinical Study Report (CSR)
• Monitor external service providers (central labs, IXRS, ePRO, etc.) against contracted goals, timelines and budget
• Develop and maintain study plans such as the global study management plan and study project plan, including quality and risk management inputs
• Track performance against KPIs and milestones, report risks to the CPT with proposed mitigations, and report quality issues and CAPAs
• Oversee Trial Master File completion, including TMF plan, Expected Document List and ongoing QC
• Ensure compliance with governance controls (Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency) and keep studies inspection-ready per ICH-GCP
• Manage study budget re-forecasting and budget progress reporting to the CPT
• Provide regular performance feedback and mentor less experienced colleagues; also work on non-drug SMO improvement projects

Required profile

• University degree (or equivalent), preferably in medical or biological sciences or a discipline associated with clinical research
• 7 years of relevant clinical experience in R&D in the pharmaceutical industry, including 2 years of project management experience, or an equivalent combination of education, training and experience
• Knowledge of clinical research regulatory requirements and clinical study management processes

Required skills

• Solid project management skills and knowledge of relevant tools
• Team leadership and strong communication and interpersonal skills
• Strategic thinking, organization, problem solving and ability to manage competing priorities