My client is a clinical research organisation with positive reputation, who provides professional service for clinical studies to pharmaceutical and biotechnology companies. They start offering clincial and laboratory services in China, Korea, Japan and Taiwan. Regarding the organisation culture, my client values every employee, offers competitive package and training programs. Moreover, they also value the teamwork and flexible working style.

職務說明

• Develops clinical plans and guidelines, including clinical monitoring plans. Assures compliance with monitoring intervals according to the project requirements.
• Control and manage the project within the budget, the scope of work and the timeline.
• Lead project team to complete project specific management plan, tools and templates. Supervises overall project planning, execution, and risk management.
• Work with the line manager of the project team member to facilitate issue resolution.
• Reviews the study scope of work, budget, and protocol content. Provides training to project teams on protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study.

理想的應徵者

• Minimum master degree (major in nursing, pharmacy or other science-related background).
• 5+ years experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 3 years direct experience in clinical project planning, coordination and management, with multi-national trial exposure.
• Extensive understanding of SOPs, Work Instructions (WI), FDA, and local regulations as well as ICH GCP guidelines.
• Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment.
• Fluent communication skill in English and Chinese.

福利待遇

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