About the job

Main responsibilities:

--Provide strategic operation input for data gap analysis and Independent Expert Group Program (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: Bachelor’s degree in medicine/ biology or above, master’s degree is preferred

Experience:

• 3-5 years above working experience in pharmaceutical/CRO industry
• Have the following experience is preferable:
  • 2 years of clinical trial management, preferable specialized in medical affaire study, including Company RWE study, ISS and etc.
  • independent project management experience with at least 4 projects lasted for 1 year, and with more than five different stakeholders

Core competencies:

• Fluent spoken and written English and mandarin
• Good cross-function coordination and communication skills
• Planning and Organising
• Quality Orientation
• Business Acumen
• Working under pressure

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