CRC manager
零氪科技(北京)有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:计算机软件 制药/生物工程
职位信息
- 发布日期:2017-03-30
- 工作地点:北京-海淀区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语
- 职位月薪:1-1.5万/月
- 职位类别:临床研究员 临床协调员
职位描述
职位描述:
工作简介
Job Outline
在较少的监督下,管理研究中心管理服务部门的人员、资料、系统和财务资源。保证研究中心管理服务部门员工获得必备的技能来开展各自的工作,确保其提供的服务符合标准操作规程、临床试验规范和监管法规,同时满足客户期望和工作范围,符合质量、时限及预算的要求。
Manage the human, material, system and fiscal resources in site management service function with less supervision. Ensure that site management service staffs gain the necessary skills to perform their respective job responsibilities. Ensure the service delivery in accordance with SOPs, GCP and regulations, client expectation and SOW, and meet the quality, timeline and budget metrics.
职责
RESPONSIBILITIES
按照商定的工作范围要求、标准操作规程及规章制度管理员工。工作职责包括制定计划、分配工作、指导工作;评估表现、指导专业发展;奖惩员工;解决员工相互关系问题。审批人力资源事宜。
Manage staff in accordance with agreed working scope, SOPs and regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
通过审核和面试候选人,进行新员工挑选和入职流程。结合人力资源部和培训计划,进行新员工入职培训。适时陪同员工到研究中心访视。
Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct on boarding training for new staff in conjunction with Human Resources and training programs. Perform accompanied site visits as appropriate.
确保员工有正确的资料、系统访问权和培训,以保证工作任务的顺利完成。监督培训计划的实施、SOP审核以及辅导培训经验(如适用)。
Ensure that staffs have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
确保根据员工的经验及其所接受的培训将其分配到相应的临床研究项目。
Ensure the resources allocation to projects by assigning staff to clinical studies that are appropriate to their experience and training.
通过定期审查和评估工作成果,管理指派员工的临床工作质量。
Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
发现质量风险和问题,制定合理的改善计划,以避免或纠正员工工作上的不足。
Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
通过对员工进行定期审核和报告管理团队概述的问题,确保员工工作达到既定的工作量和质量指标。
Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by management team.
为业务拓展团队撰写新项目的计划书提供支持,并协助联系客户。
Provide support to BD team on the proposal development for a new project and clients contact.
完成直线经理分配的其他任务。
Perform other duties as assigned by line manager.
知识、技能和能力要求
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
深入了解临床研发和监管法规要求的相关知识。
In depth of knowledge of applicable clinical development and regulatory requirements.
良好的领导能力,高效的培训和指导技能。
Good leadership skills, effective mentoring and training skills.
熟练使用Word, Excel和PowerPoint微软办公软件。
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
较强的书面和口头表达能力,优秀的演讲技能。
Strong written and verbal communication skills, excellent presentation skill.
英语口语流畅,书面表达能力良好。
Fluent in English spoken and written.
良好的策划、组织、解决问题的能力。
Good planning, organizational and problem-solving skills
有效的时间管理技能和管理优先级冲突事情的能力。
Effective time management skills and ability to manage competing priorities.
能独立完成任务,根据优先级选择重点,寻找资源,能解决问题,适应在团队中工作。
Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
能够严格保密。
Ability to maintain confidentiality.
教育和经验的最低要求
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
大专学历,临床医学、药理学、护理、卫生保健或其他医学相关专业
School diploma/certificate in clinical medicine, pharmacology, nursing, health care or other medical related discipline.
四年以上研究中心管理工作或类似工作经验。
At least 4 years of site management work experience or equivalent experience.
大学英语四级或以上。
At least CET- 4 level.
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工作简介
Job Outline
在较少的监督下,管理研究中心管理服务部门的人员、资料、系统和财务资源。保证研究中心管理服务部门员工获得必备的技能来开展各自的工作,确保其提供的服务符合标准操作规程、临床试验规范和监管法规,同时满足客户期望和工作范围,符合质量、时限及预算的要求。
Manage the human, material, system and fiscal resources in site management service function with less supervision. Ensure that site management service staffs gain the necessary skills to perform their respective job responsibilities. Ensure the service delivery in accordance with SOPs, GCP and regulations, client expectation and SOW, and meet the quality, timeline and budget metrics.
职责
RESPONSIBILITIES
按照商定的工作范围要求、标准操作规程及规章制度管理员工。工作职责包括制定计划、分配工作、指导工作;评估表现、指导专业发展;奖惩员工;解决员工相互关系问题。审批人力资源事宜。
Manage staff in accordance with agreed working scope, SOPs and regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
通过审核和面试候选人,进行新员工挑选和入职流程。结合人力资源部和培训计划,进行新员工入职培训。适时陪同员工到研究中心访视。
Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct on boarding training for new staff in conjunction with Human Resources and training programs. Perform accompanied site visits as appropriate.
确保员工有正确的资料、系统访问权和培训,以保证工作任务的顺利完成。监督培训计划的实施、SOP审核以及辅导培训经验(如适用)。
Ensure that staffs have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
确保根据员工的经验及其所接受的培训将其分配到相应的临床研究项目。
Ensure the resources allocation to projects by assigning staff to clinical studies that are appropriate to their experience and training.
通过定期审查和评估工作成果,管理指派员工的临床工作质量。
Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
发现质量风险和问题,制定合理的改善计划,以避免或纠正员工工作上的不足。
Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
通过对员工进行定期审核和报告管理团队概述的问题,确保员工工作达到既定的工作量和质量指标。
Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by management team.
为业务拓展团队撰写新项目的计划书提供支持,并协助联系客户。
Provide support to BD team on the proposal development for a new project and clients contact.
完成直线经理分配的其他任务。
Perform other duties as assigned by line manager.
知识、技能和能力要求
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
深入了解临床研发和监管法规要求的相关知识。
In depth of knowledge of applicable clinical development and regulatory requirements.
良好的领导能力,高效的培训和指导技能。
Good leadership skills, effective mentoring and training skills.
熟练使用Word, Excel和PowerPoint微软办公软件。
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
较强的书面和口头表达能力,优秀的演讲技能。
Strong written and verbal communication skills, excellent presentation skill.
英语口语流畅,书面表达能力良好。
Fluent in English spoken and written.
良好的策划、组织、解决问题的能力。
Good planning, organizational and problem-solving skills
有效的时间管理技能和管理优先级冲突事情的能力。
Effective time management skills and ability to manage competing priorities.
能独立完成任务,根据优先级选择重点,寻找资源,能解决问题,适应在团队中工作。
Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
能够严格保密。
Ability to maintain confidentiality.
教育和经验的最低要求
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
大专学历,临床医学、药理学、护理、卫生保健或其他医学相关专业
School diploma/certificate in clinical medicine, pharmacology, nursing, health care or other medical related discipline.
四年以上研究中心管理工作或类似工作经验。
At least 4 years of site management work experience or equivalent experience.
大学英语四级或以上。
At least CET- 4 level.
职能类别: 临床研究员 临床协调员
公司介绍
LinkDoc致力于打造全球最领先的医疗数据解决方案及肿瘤大数据平台。以数据的力量,帮助中国医疗机构及临床专家研究和解决科研及临床问题,促进医疗水平的不断提高。
LinkDoc拥有国内领先的临床数据融合系统,帮助医院和科室建立结构化病历数据库,提高诊断、随访、科研等各环节的效率,建立临床科研与患者服务的数字化生态环境。
LinkDoc拥有国内领先的临床数据融合系统,帮助医院和科室建立结构化病历数据库,提高诊断、随访、科研等各环节的效率,建立临床科研与患者服务的数字化生态环境。
联系方式
- 公司地址:上班地址:海淀区海淀大街8号中钢国际A座8层