岗位职责:
1. Independently be responsible for all activities of the clinicalresearch, including clinical site select******** study initiationv******** training of on-site personnel, study close an********monitoring with on-site audits of clinical data for accuracy an********,an******** report preparationan********.独立负责临床试验中的所有环节,包括临床试验单位的选择,临床试验启动、人员培训、项目结题、临床监察,进一步负责临床数据准确性以及完整性,并且准备和获得临床试验报告。
2. Prepare study protocols, investigator manuals, site specificinstruction manuals an******** case reportforms.准备临床试验相关的所有文档,包括临床方案、研究者手册、临床单位的操作指南以及病例报告表等。
3. Assist with the management of key study parameters, including******** clinical research pro******** start-up act******** enrollment,data collect********etc..协助管理临床试验中的所有关键性因素,包括文档、临床试验所用产品、临床试验启动、病例入组、数据收集等。
4. Slove the problems or issues that coul******** the results or timelycompletion of the trial. 解决所有可能会影响到临床试验结果或者临床试验结束时间的各种问题。
任职要求:
1. 工作经验:Minimum of 3 years experiences with In Vitro Diagnostic (IVD),especially in molecular diagnostics or immunodiagnostics. Having theworking experience in the MCN company or local well-known company ispreferred.至少3年以上体外诊断试剂领域临床试验工作经验,尤其是分子诊断或者免疫学诊断相关领域的经验。具有跨国企业或者本土知名企业工作经验者优先。
2. 教育背景:Bachelor's Degree or above of Medical/Biological relate********.Master degree is prefeered. 医学/生物学相关专业本科以上学历,研究生学历优先。
3.语言技能:Fluent Reading an******** English; Communication: Highlydevelope******** skills; Characters: Well organizing details of theproject, an******** to details. Willing to travel.熟练的英语阅读和写作能力;相熟的沟通能力;良好的细节管理能力。
4.技术能力:Clinical Research Skill******** Organizing clinical trial ofMedical Device********, being familiar with GCP an******** guidelines.Multi-tasks Managemen******** Having experience on the multi-tasksmanagement, have the capability to handle an******** more than 3projects at the same time.临床试验技巧:组织过医疗器械/体外诊断试剂临床试验,熟悉GCP和CFDA的技术指南;多项目管理:拥有多项目管理经验,并且有能力协调和开展多个项目。