職位描述
職位描述：
對所負(fù)責(zé)的臨床研究項目進(jìn)行全面的管理；
- 對所負(fù)責(zé)的臨床研究項目組成員進(jìn)行培訓(xùn)；
- 在相關(guān)領(lǐng)域?qū)RA團(tuán)隊進(jìn)行指導(dǎo)，特別是工作技巧方面；
- 管理CRA團(tuán)隊，確保團(tuán)隊人員工作有效，專業(yè)，負(fù)責(zé)；
- 按照項目時限，制定項目時間計劃，整體把握試驗進(jìn)度；
- 管理項目財務(wù)，制定項目年度，月度預(yù)算；
- 參與臨床研究關(guān)鍵步驟；
- 通過項目管理工作，維護(hù)公司和研究中心良好的合作關(guān)系；
- 其他項目管理工作
任職資格：
- 醫(yī)學(xué)、藥學(xué)相關(guān)專業(yè)本科以上學(xué)歷；
- 至少3年以上臨床監(jiān)查員工作經(jīng)歷；
- 至少1年以上臨床研究管理經(jīng)歷；
- 熟悉藥物臨床研究質(zhì)量管理規(guī)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(tuán)隊合作精神；
- 注重工作細(xì)節(jié)，注重團(tuán)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
