지디에프아이 브레인셀연구소

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Project Management

국제법령과 글로벌 임상표준화를 충족하는 GDFI Braincell Laboratory

Global Study의 시작단계부터 해외임상에 경험있는 Project Manager와의 업무 협력을 통해 미국, EU, 동유럽, 일본, 대만, 중국 등 전세계적 해외임상 Network을 구축하여 고객사에 임상 수탁업무를 제공하고 있습니다.

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국내 고객이 해외임상 계획 시 임상전략과 수행 방안에 대한 계획 수립 및 진행업무를 수탁 대행하고 있으며, 해외고객이 국내임상을 계획할시 국내임상 전반에 관한 상담과 국내임상전략과 수행방안을 제공하는 수탁대행 업무를 진행합니다.

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임상시험의 핵심사항인 시험 대상자 모집 시스템을 운영함으로써 효율적인 수행과제의 계획 일정에 대한 진도관리를 지원하고 있습니다.

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3-1. Project Manager (PM)

  • Provide strong project leadership to motivate and inspire project team
  • Participate in CRO review, selection, and negotiation for each study
  • Develop, implement and maintain workable project plans
  • Demonstrate strong interpersonal and communication skills across all dimensions
  • Negotiate and resolve disputes effectively and amicably both internally and externally
  • Establish and maintain positive and effective working relationships with external vendors and clients.
  • Provide strong project leadership to motivate and inspire project team
  • Participate in CRO review, selection, and negotiation for each study
  • Develop, implement and maintain workable project plans
  • Demonstrate strong interpersonal and communication skills across all dimensions
  • Negotiate and resolve disputes effectively and amicably both internally and externally
  • Establish and maintain positive and effective working relationships with external vendors and clients.
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3-2. Multinational Collaborative Clinical Study

  • Feasibility Study
  • Project Management (Primary contact with Overseas Client and CROs)
  • Monitoring
  • Medical Monitoring
  • Vendor management
  • Translation & printing of clinical dossiers
  • Global QA Audit & Inspection Support
  • Feasibility Study
  • Project Management (Primary contact with Overseas Client and CROs)
  • Monitoring
  • Medical Monitoring
  • Vendor management
  • Translation & printing of clinical dossiers
  • Global QA Audit & Inspection Support
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3-3. Enrollment Acceleration Service

  • Patient Registration / Enrollment Services
  • Patient registration (receipt by Fax)
  • Eligibility assessment
  • Allocation of Investigational Products (including dynamic allocation)
  • Enrollment Acceleration Services (Task Force Team)
  • Task Force for Sponsors (Task Force Team)
  • Patient Registration / Enrollment Services
  • Patient registration (receipt by Fax)
  • Eligibility assessment
  • Allocation of Investigational Products (including dynamic allocation)
  • Enrollment Acceleration Services (Task Force Team)
  • Task Force for Sponsors (Task Force Team)
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