職位描述
職位描述：
對所負責的臨床研究項目進行全面的管理；
- 對所負責的臨床研究項目組成員進行培訓；
- 在相關領域對CRA團隊進行指導，特別是工作技巧方面；
- 管理CRA團隊，確保團隊人員工作有效，專業，負責；
- 按照項目時限，制定項目時間計劃，整體把握試驗進度；
- 管理項目財務，制定項目年度，月度預算；
- 參與臨床研究關鍵步驟；
- 通過項目管理工作，維護公司和研究中心良好的合作關系；
- 其他項目管理工作
任職資格：
- 醫學、藥學相關專業本科以上學歷；
- 至少3年以上臨床監查員工作經歷；
- 至少1年以上臨床研究管理經歷；
- 熟悉藥物臨床研究質量管理規范和臨床研究操作流程；
- 具有管理項目能力，具有較強的分析問題和解決問題的能力；
- 具有有效的溝通技巧；工作有條理，計劃性強；
- 具有自我激勵和積極的團隊合作精神；
- 注重工作細節，注重團隊合作；
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
