Job ID: 11620 Position Summary

China, Shanghai | Full-time | Job ID: 11620

Position Summary:

Supports clinical operational effectiveness, training enablement, vendor management and serves as a key coordination point with QA for China Clinical Operations.

Works closely with study teams to ensure processes are practical, consistent, and aligned with internal procedures and regulatory requirements. This role focuses on enabling smooth study execution through process improvement, training delivery, and coordination of key operational activities, while partnering with QA to support compliance and inspection readiness.

Your main responsibilities are:

• Clinical Operations Excellence · Support the development and continuous improvement of study-related processes and working practices. · Identify practical improvement opportunities based on study experience and operational challenges. · Assist study teams in implementing fit-for-purpose processes aligned with company procedure and regulatory requirements. · Support the update and maintenance of process documents and working instructions in collaboration with QA. · Facilitate implementation of systems supporting clinical operations (e.g., eTMF, CTMS, RBM) from a user and operational perspective.
• Training & Capability Development · Coordinate onboarding and role-specific training for China Clinical Operations team members. · Support the development and update of training materials based on current processes and study needs. · Track CO team training completion and identify gaps in collaboration with line managers. · Facilitate knowledge sharing within the team, including lessons learned and best practices. · Identify knowledge and skill gaps within the CO team and coordinate with internal or external partners to address these gaps through appropriate training activities.
• GCDO Vendor Management: · Track China-specific vendor (Regional CRO, SMO, referral Co., etc.) performance, including KPIs, risk assessment and continuous improvement plans, in alignment with GCDO Vendor Management framework. · Support vendor onboarding and communication of operational expectations in partnership with QA and the procurement team.
• Audit and Inspection Coordination: · Act as the key coordination point with QA for audit and inspection from China CO team’s perspective. · Support the study team in issue investigation and CAPA development. · Lead audit response within Clinical Operation to ensure all the audit observations are addressed properly within timeline. · Share common findings, lessons learned, and good practices across studies within the CO team.

What you have to offer:

• Bachelor’s or above degree in Life Sciences, preferably in Medicine, Pharmacy or Health Sciences. Master’s degree preferred.
• At least 10+ years of experience in clinical operations, with substantial exposure to process excellence, quality management, or operational governance.
• Proven experience in leading teams and managing cross-functional initiatives in a complex, global or matrix en