职位描述
职位描述：
对所负责的临床研究项目进行全面的管理；
- 对所负责的临床研究项目组成员进行培训；
- 在相关领域对CRA团队进行指导，特别是工作技巧方面；
- 管理CRA团队，确保团队人员工作有效，专业，负责；
- 按照项目时限，制定项目时间计划，整体把握试验进度；
- 管理项目财务，制定项目年度，月度预算；
- 参与临床研究关键步骤；
- 通过项目管理工作，维护公司和研究中心良好的合作关系；
- 其他项目管理工作
任职资格：
- 医学、药学相关专业本科以上学历；
- 至少3年以上临床监查员工作经历；
- 至少1年以上临床研究管理经历；
- 熟悉药物临床研究质量管理规范和临床研究操作流程；
- 具有管理项目能力，具有较强的分析问题和解决问题的能力；
- 具有有效的沟通技巧；工作有条理，计划性强；
- 具有自我激励和积极的团队合作精神；
- 注重工作细节，注重团队合作；
Key Accountabilities/Core Job Responsibilities
• Responsible for all operational aspects and progress of clinical trial from a study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators
• Serves as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional groups to achieve deliverables
• Oversees/facilitates site feasibility/selection processes
• Develops/oversees subject recruitment/retention strategy and related initiatives
• Provides operational and strategic input and/or approves study documents such as synopsis, protocol, Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc.
• Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate
• Responsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, issues escalations)
• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and vendors
• Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
• Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
• Conducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed
