Meidical - Clinical Operation Manager - Shanghai

Main responsibilities:

-Provide strategic operation input for data gap analysis and Integrated Evidence Generation Plan (IEGP) for assigned therapy areas as needed.

- Develop clinical study planning according to agreed business priorities.

-Lead medical studies, including Company Sponsored Study (CSS) & External Sponsor Research (ESR), global and local review process.

-Work on overall study execution, including vendor management to make sure on-time delivery of all study key milestones, identify and eliminate potential risks of study delays meet the commitment KPIs with/without CSO.

-Track study status and update monthly performance reports.

-Manage External Sponsor Research (ESR) from proposal/protocol review, contract, study progress follow up and payment, and etc.

-Ensure compliant management of all ISS/CSS status and documents in required systems.

-Liaise with Medical, CSO, and global cross-functional teams to ensure proper planning and execution of medical-funded studies according to business priorities, agreed timelines, and budgets.

-Budget Evaluation & Management: budget evaluations and review, budget transfers and increases, and budget follow-up and identify potential issues and serve as contact person for Controlling, CSU, CSO, global line functions and etc.

-Ensure compliance, governance and risk management of responsible studies, including internal audit, internal control and related activities.

-Support for external key stakeholders’ study operation related communication as need.

-Undertake other tasks as required.

About you

Education: Master’s degree in medicine/ biology or above

Experience:

• 8 years above working experience in pharmaceutical/CRO industry
• Minimal 4 years of clinical trial management, preferable specialized in medical affaire study, including Company RWE study, ISS and etc.
• Minimal 2 years CRO experience.
• independent project management experience with at least 6 projects lasted for 1 year, and with more than five different stakeholders
• PMP is preferred

Core competencies:

·        Excellent spoken and written English and mandarin

·        Good cross-function coordination and communication skills

• Influencing, communication
• Planning and Organising
• Quality Orientation
• Building Partnership
• Initiative and leadership
• Business Acumen
• Working under pressure