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:
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8 years above working experience in pharmaceutical/CRO industry
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Minimal 4 years of clinical trial management, preferable specialized in medical affaire study, including Company RWE study, ISS and etc.
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Minimal 2 years CRO experience.
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independent project management experience with at least 6 projects lasted for 1 year, and with more than five different stakeholders
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PMP is preferred
Core competencies:
- Excellent spoken and written English and mandarin
- Good cross-function coordination and communication skills
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Influencing, communication
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Planning and Organising
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Quality Orientation
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Building Partnership
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Initiative and leadership
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Business Acumen
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Working under pressure
