Site Start-Up Specialist (Shanghai/Beijing)
We are looking for suitable individuals to fill the position of :
Site Start-Up Specialist
- 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.
- 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
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