Senior Manager, Country Study Enablement & TMF Management

Typical Accountabilities

• Strategic Planning & Team Leadership: Formulate and execute long-term and annual operational plans for country study enablement and TMF management; lead a team, build a collaborative learning culture, and ensure rational resource allocation and utilization.
• End-to-End Process Management & Optimization: Be responsible for establishing, maintaining and continuously optimizing the end-to-end country study enablement (e.g., meeting organization, payment processing, equipment management, trial disclosure, digital development, etc.) and TMF management systems from study initiation to close-out. Lead cross-functional process improvement projects, identify pain points, introduce best practices, and enhance overall operational efficiency and quality.
• TMF Operational Excellence & Quality Oversight: As the ultimate accountable person for TMF management, ensure that TMFs for all trials comply with internal SOPs, ICH-GCP and regulatory requirements, and maintain a real-time, accurate, complete and audit-ready state. Establish a proactive quality risk control mechanism and drive the digitalization and intellectualization of TMF management.
• Business Support & Delivery Assurance: Provide strategic and centralized operational support to the Development Operations study teams to ensure the on-schedule and high-quality delivery of all clinical trial tasks. Proactively participate in business planning and provide professional input for study feasibility, budget and timeline management from the perspective of enabling functions.
• System & Digital Innovation: Lead or deeply participate in the evaluation, implementation, optimization and lifecycle management of clinical operation-related systems (e.g., CTMS, eTMF, VCV, etc.). Advocate and drive the application of digital solutions to simplify workflows, improve data quality and enhance team productivity.
• Internal & External Collaboration & Influence: Act as a key liaison to establish and maintain strong collaborative relationships with all internal functional departments (Global Study Teams, Site Management, Quality Assurance, Medical Affairs, Regulatory Affairs, etc.) and external partners (CDE, Institutions, vendors/CROs/PROs/SMOs). As China representative to speak on regional or global platforms and promote the best practices in China.
• Talent Development & Capability Building: Be responsible for the construction of the team talent echelon, including recruitment, coaching, succession planning and professional capability development planning. Design and drive the training system for clinical operations enablement and TMF management to improve the overall professional literacy of the team.
• Compliance & Risk Management: Ensure all team activities comply with AZ’s code of conduct, ICH-GCP and Chinese regulations; proactively identify and manage operational and compliance risks, and foster a culture of continuous improvement.

Date Posted

15-7月-2026

Closing Date

30-8月-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.