CRC Supervisor/Manager
昆拓信诚医药研发(北京)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-04-26
- 工作地点:北京
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:临床协调员 临床研究员
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.
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.
公司介绍
昆拓信诚医药研发(北京)有限公司是艾昆纬公司投资全资子公司,为美资CRO公司,依托艾昆纬公司全球高标准的质量管理系统和资源,昆拓形成了涵盖所有运营部门的完备标准操作流程(SOP)系统以及质量控制体系。
昆拓秉承诚信、责任、合作、创新的公司文化,致力于成为中国本土临床研究服务的领跑者,以艾昆纬为依托,用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围,制定了严格的人才培养机制,为员工提供了良好的培训以及职业发展平台。
人员一经录用,公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外,公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。
昆拓秉承诚信、责任、合作、创新的公司文化,致力于成为中国本土临床研究服务的领跑者,以艾昆纬为依托,用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围,制定了严格的人才培养机制,为员工提供了良好的培训以及职业发展平台。
人员一经录用,公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外,公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。
联系方式
- Email:hr01@kuntuo.com
- 公司地址:武汉协和