JOBS      

At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health.

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical Solutions and Medical Aesthetics is also what differentiates us — the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together we advocate for better health and wellness through solutions that provide even-greater certainty and peace of mind.

Clinical Affair Manager

Location: Beijing, Beijing Shi CN

Apply

Job Number: 957

External Description:

Job Title: Clinical Affair Manager
临床项目经理
Division: RAQA
注册及质量管理
HR-Location: China
中国
Reporting Line: Sr. Medical & Regulatory Affairs Manager, APAC.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
豪洛捷是一家领先同侪,集研发、制造和供应优质分子诊断产品和服务、医疗影像系统、外科手术产品于一体的公司,以服务全球妇女医疗健康需求为己任。豪洛捷公司致力于通过早期诊断、微创的治疗方式帮助全球妇女得以享受更健康、更长寿的生活。目前Hologic亟需优秀人才的加入。

Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
有远见的人一起致力于健康诊断成就了今天的Hologic。我们坚信,人才是公司宝贵的财富,只有通过招聘、培训、发展、保留最优秀的人才,我们才能持续成功。

Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
我们的工作氛围是促进创新和以客户为中心。我们为员工提供最先进的工具和技术,合作和充满激情的工作环境,以提升世界各地的医疗保健水平。

We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
公司总部位于马萨诸塞州,在北美、欧洲、拉丁美洲、澳大利亚、亚洲设置了运营中心。我们将集中公司资源致力于提升全球的健康水平。

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
我们正在迅速成长,我们将更加关注员工、成长与未来。这是一个激动人心的历史时刻,可以访问我们的网站以了解更多的职业生涯的机会。

Hologic has China commercial organization with headquarter in Beijing. We aim to build the China Organization into an exciting place to work and grow professionally.
豪洛捷在中国设置了完整的商业机构,总部位于北京,我们致力于打造积极的、专业的商业运营机构。


SUMMARY OF DUTIES AND RESPONSIBILITIES
主要职责
• Take charge of the management and operation of clinical trial projects, coordinate cross-functional team(s) in the execution of clinical trials
• 全面负责临床试验项目的管理和运作,协调临床试验项目实施过程中不同职能团队的日常工作
• Manage the planning and execution of clinical studies, including data collection activities; set up Clinical Trail strategy and overall control Clinical Trail timeline; build SOPs related with Clinical Trail
管理临床科研活动,包括数据收集,的计划和开展;制定临床试验策略并全面管控临床试验的时间安排;建立临床试验相关标准操作流程
• Establish project plan with clear timeline and deliverables and ensure the implementation of the defined plan
建立具备清晰时间安排和可交付结果的项目计划并确保计划的顺利完成
• Responsible for CROs selection as needed
必要时负责合同研究组织的筛选
• Play a leading role in the qualification of clinical trial sites to be responsible for site selection, site qualification, site monitoring, site management, if necessary negotiate site contracts
主导临床研究基地的资格管理,包括基地筛选、基地考核、基地监测、基地管理以及必要情况下基地合同的协商
• Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion
通过识别和管理合格成员、建立审计步骤和确保输入数据库的数据的准确性与及时性来对所有试验进行监测
• Establish scientific methods for design and implementation of study protocols and data collection systems that meet quality and regulatory requirements
建立科学方法以设计和完成符合质量和法规要求的临床试验计划表以及数据收集系统
• Lead reviews of data periodically, analyst and interpret clinical trial data, prepare clinical study final reports & close the trial
带领阶段性数据复查,分析和解释临床试验数据,准备临床研究报告并结束试验
• Interact with various internal/external groups to facilitate completion of studies for inclusion in regulatory submissions for devices
与内外部团队配合以推动设备注册所需试验的完成
• Conform to applicable regulations and standards and company quality policies, ensure that all aspects of GCP for Medical Device are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development
遵照适用法规和标准以及公司质量管理方针,在临床试验最初会议以及后续标准操作流程的建立过程中提供相关培训,以确保临床试验的各个方面以及各个阶段全部符合《医疗器械临床试验质量管理规范》的规定


QUALIFICATIONS
资格要求
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
为能够成功地完成以上工作,个人必须能够满意地完成各项基本任务。以下列出的要求代表了需要的基本知识、技能、和/或能力。可以作出合理调节以便有能力缺陷的个人能够承担基本职能。

• Good knowledge of clinical trial process and the process of sites
熟悉临床试验流程以及试验基地操作流程
• Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
有能力处理复杂问题,分析形势或数据并深入评估不同因素
• Can exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
能够在大范围的试验模式以及试验思路中进行判断,为获取结果选择最佳方式、技术和评估指标
• Knows how to go through the proper channels to get things done
知道如何通过适当渠道确保工作的完成
• Sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
设定明确目的和目标,具备针对任务周期长度和困难程度进行规划的能力,能够将项目分解成为具体任务和步骤
• Ability to simplify complex processes and to organize people and activities
了解如何简化复杂流程以及组织人员和活动
• Excellent interpersonal skills with proven ability to work both in a team-oriented environment and independently
出色的人际沟通技巧,既能够与团队合作也能独立承担工作任务
• Experience working independently in a fast-paced environment with rapidly changing priorities
具备在快节奏的环境中,优先顺序迅速变化的情况下独立工作的能力
• Chinese native speaker with fluent English in both written and spoken
中文母语,流利的英文口语和书面表达能力


EDUCATION

• MSc in a scientific field (biology, clinical, pharmacy), Medical background preferred
科学领域硕士学历(生物、临床、制药),医疗背景优先


EXPERIENCE
• Around 7 years’ clinical research experiences in relevant industry
7年左右相关行业临床研究工作经验
• Experience in a GMP and/or FDA regulated environment with detailed knowledge of GCP for Medical Device including basic understanding of regulatory requirements, Chinese regulation preferred
• GMP和/或FDA法规环境工作经验,同时具备关于《医疗器械临床试验质量管理规范》的详细了解,包括对于中国注册法规相关要求的基本了解者优先
• Experience in CER preparation is preferred

Job Number: 957

Community / Marketing Title: Clinical Affair Manager

Location_formattedLocationLong: Beijing, Beijing Shi CN