苏州招聘

In this role, you have the opportunity to

• Plan, Lead and be responsible for the Delivery clinical trials to  timeline, cost, and quality from study protocol in compliance with GCP/SOPs, local regulations and the Clinical Study Protocol under supervision of line management with a certain degree of independence

• Responsible for feasibility study at project level, ensure the feasibility truly reflected by analyzing information collected from each site.

• Provide co-monitoring to CRAs to ensure study quality.

• Develop and maintain excellent working relationships with external and internal customers, and selected CRO vendors to ensure the smoothly and timely delivery of clinical studies

 

You are responsible for

• Clinical Trial Budget, Timeline, quality control planning.

• Trial Essential documents preparation such as Protocol, CRF, ICF draft/finalization coordination.

• Participates in the identification of potential investigators and clinical sites conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.

• Participates in negotiating site/investigator grant within trial specific budget

• Co-Conducts clinical site initiation visits; advises and trains site personnel on Philips internal and regulatory requirements for clinical trial conduct; participates and/or conducts site meetings

• Co-erifies that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.

• Co-Verifies that site facilities, including laboratories and equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.

• Responsible for trial materials distribution and accountability coordination.

• Oversee and reports trial progress and ensures timely subject recruitment and trial completion.

• Oversee the site monitoring visits and follow-up to ensure that all clinical aspects of studies are being carried out in accordance with the protocol, regulatory requirements, GCP guidelines and SOPs.

• Identifies trial site problems and initiates/implements corrective actions with the site monitors.

• Ensures high quality CRF/EDC completion in a timely manner and performs source data verification

• Ensures that the receipt, use and return of the investigational product(s) at the trial sites are controlled and documented adequately

• Performs trial document management and ensures both trial / site specified TMFs and Investigator Folders are completed according to CFDA GCP, ISO14155, ICH GCP and internal SOPs.

• Ensures all SAEs are appropriately reported within the time frame required by GCP, the protocol and the SOPs.

• Ensures that the monitoring visit reports after each trial-site visit or trial related communication done by the site monitors.

• Ensures the investigator payments are processed according to study site budget plan and clinical trial agreement with the investigator.

• Performs miscellaneous job-related duties as assigned.

 

You are a part of

Great china Q&R team

 

To succeed in this role, you should have the following skills and experience

• Experience in clinical trial project management, even as a Sr. Clinical Research Associate/Specialist

• Bachelor’s degree in clinical medicine or a life/biological science

• Above 4 years clinical operation experience in Medical Device/Pharmaceutical corporate or CRO (Clinical Research Organization)

• Familiar with GCP and relevant local regulations

• Good command of spoken and written English

• Good self-motivation and self-organization

• Good interpersonal skills, diplomacy and the ability to motivate and organize other

• Computer literacy essential

• 30-50% travel required

 

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

 

• A professional but fun workplace, A healthy work-life balance environment;

• An energetic, genuine, inventive, supportive and dynamic team atmosphere;

 

 

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

 

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

 

荷兰皇家飞利浦公司是一家领先的健康科技公司，致力于在从健康生活方式、疾病预防、到诊断、治疗和家庭护理的整个“健康关护全程”，凭借先进的技术、丰富的临床经验和深刻的消费者洞察，不断推出整合的创新解决方案，助力健康医疗系统实现四重目标——提高大众健康水平、提高医护人员满意度、改善患者体验，并降低关护成本。飞利浦的愿景是通过有意义的创新，令世界更健康、更可持续的发展，到2030年每年改善25亿人的生活。

        飞利浦公司总部位于荷兰，2021年销售额达172亿欧元，在全球拥有大约78,000名员工，销售和服务遍布世界100多个国家。公司目前在诊断影像、图像引导治疗、病人监护、医疗信息化以及消费者健康和家庭护理领域处于领导地位。

        在飞利浦，每一个人，都至关重要。这是我们始终坚持的信念。在飞利浦，你将用数字化驱动有意义的创新，积极影响自己与数十亿人的生活，践行改善人类生活的使命。我们全心营造多元包容的工作环境，平等互助的工作氛围，让你的独特之处得到充分尊重和欣赏，鼓励你释放真我，以梦为马，不负韶华。本着 “立足中国，辐射全球” 的理念，我们通过布局广泛的业务线，为你带来广阔的平台、丰富的学习资源、多样的内部发展机会，助你成为具备全球化视野和本土深度的一专多能复合型稀缺人才。

创美好，做真我，迎蜕变。
我们深信每一个你都卓尔不凡, 更期待与志同道合的你笃行致远。