SERVICES

Project Management

Project Management

Project Manager는 Project management plan을 기획하고 Project team management, Timeline management, Quality management, Risk management, Vendor management까지 총괄하는 역할을 담당합니다. Project team과의 긴밀한 협력을 통해 고객사의 임상시험이 성공적으로 진행될 수 있도록 경험과 역량을 최대한 활용하여 Project를 운영하고 있습니다.

축적된 경험과 노하우

각 전문분야에서 쌓아온 경험과 역량을 최대한 활용하여 프로젝트를 총괄 관리함으로써 계획된 시간과 비용으로 임상시험이 성공적으로 마무리될 수 있도록 운영합니다.

Project Management

Service Scope

Project management

  • Develop Project Management Plan(PMP)
  • Direct and manage work
  • Perform integrated change control
  • Optimize resource
  • Communication management
  • Monitor and control the project

Timeline management

  • Plan how the schedule will be managed
  • Define the activities
  • Sequence the activities
  • Estimate the activities duration
  • Develop the schedule
  • Monitor and control the schedule

Quality management

  • Incorporating the organizations quality policy regarding planning, managing and controlling project and product quality requirements in order to meet stakeholders objectives.
  • Define SOP list
  • Training management
  • Change control

Issue and escalation management

  • Issue occurrence reported or detected
  • Document issue
  • Triage issue to determine severity
  • Escalate the Issue
  • Further classify the severity of the Issue as needed
  • Determine RCA(Root Cause Analysis)
  • Decide on CAPA
  • Implement, document and communicate CAPA

Vendor management

  • RFI, due diligence, audit: preferred supplier
  • Develop specification and send out RFP
  • Receive and review vendor proposal
  • Award project to vender
  • Finalize contract and/or SOW/Quality agreement
  • Project kick off
  • Oversee and review