Operations Excellence Lead, Operations Excellence Lead, Clinical Operations China

中国，上海   |   全职   |   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 environment.
• BSc in Life sciences and/or Health Economics with advanced degree preferred.
• Deep knowledge of ICH Guidelines, FDA/NMPA/PMDA regulations and other applicable industry regulations, processes and practices.
• Solid experience in driving clinical operational process improvement and excellence initiatives, including defining scope, leading implementation, and tracking outcomes.
• Experience in establishing and managing governance processes to ensure compliance and operational consistency.
• Experience in developing and delivering training programs, with ability to translate knowledge into practical guidance for teams.
• Demonstrated people management experience, including team leadership, coaching, and performance development.
• The ability to apply a Global vision and a strategic mindset, and to pivot between Global and local processes and requirements; managing the needs and considerations of both in a balanced and appropriate fashion.
• Excellent interpersonal, communication, and presentation skills, with demonstrated ability to build trust and influence stakeholders at multiple levels, including senior leadership.
• A proactive, adaptable, and resilient leader who performs effectively under pressure and navigates ambiguity with confidence.
• Strong analytical and problem-solving skills, with the ability to derive insights from complex data sets.
• Fluent in reading, writing and speaking English.