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Quintiles

Site Start-Up Specialist (Shanghai/Beijing)

We are looking for suitable individuals to fill the position of :

Site Start-Up Specialist

Job Responsibilities:

  • Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
  • Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
  • Review and provide feedback to management on site performance metrics.
  • Serve as contact for investigative sites, designated project reports, communications, and customer service.
  • Resolve site issues and determine status for product shipment.
  • Work with regulatory team members or sponsor to secure authorization of regulatory documents.
  • Work with legal team members or sponsor to secure authorization of contracts.
  • Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Work with team members in preparation of regulatory submissions per work instructions.
  • May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of specialization.
  • May translate or review completed translations of critical documents.
  • May participate in feasibility and/or site identification activities.

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Requirements:

  • Bachelor’s Degree in a related field and 1 year clinical research experience; or equivalent combination of education, training and experience
  • In-depth knowledge of clinical systems, procedures, and corporate standards
  • Strong knowledge of medical terminology and regulations
  • Broad knowledge of clinical research
  • Strong knowledge of Microsoft Office and e-mail applications
  • Effective communication, organizational, and interpersonal skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to manage multiple projects
  • Attention to detail
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
Job ID: 9aacc1ce3d4befc0abaac520a0d396f1
Employment Type: Other

This job is no longer available.

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