东莞招聘

Job Description-Clinical Science Manager

In this role, you have the opportunity to

• Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs; the consistent and effective communication of clinical plans, project tracking and completion, to all internal and external stakeholders;

• Lead the clinical evaluation projects across the product lines, work closely with Regular team, product team, marketing team to develop robust and rational clinical evaluation strategy; Ensure the clinical evaluation projects successfully accomplished on time and on quality;

• As key scientific reviewer to assess the scientific and ethical of the company sponsor study & IIS; Work closely with principle investigator to conduct clinical research as a qualified researcher per need.

  You are responsible for

  • Proactively address possible risks for study data for regulatory submission and effective communication of risks if applicable;

  • Satisfaction level from CFDA for clinical evaluation report and clinical trial documentation or data;

  • Demonstrate subject matter expertise for clinical evaluation and clinical trial data interpretation;

  • Develop Clinical Evaluation Report (CER) per needs;

  • Ensure all the company-sponsored studies executed in compliance with GCP, related regulations, Philips harmonized clinical SOPs in terms of quality and timeframe;

  • Ensures the clinical study successfully complete on time and on budget;

  • Ensures the clinical study in high quality and compliant to Philips harmonized clinical SOPs and local regulation;

  • Ensures the clinical study can withstand audit scrutiny by internal clinical trial audit or Regulatory entity where the risk of failure can affect product registration;

  • Ensures that all internal and external collaborating staff are appropriately organized, trained and managed to execute the terms of a research project per protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy;

  • Actively interfaces with various internal and external stakeholders including clinical science teams, internal customers, Regulatory, Legal, Quality, CRO/vendor staff, Key Opinion Leaders and clinical research staff as the subject matter expert for clinical GCPs;

  • Proactively identifies and independently prepares high quality clinical trial execution, project management, and reporting documentation (Protocol, Investigator Brochure and Inform Consent Form).

    You are a part of

    Great China Q&R team

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

• Master or PhD in medicine or life science education background;

• At least 2 years in Clinical Evaluation;

• At least 3-5 years in Clinical Trial project management;

• Demonstrated expertise in CFDA regulatory requirements and data interpretation;

• Demonstrated expertise in GCP for the conduct of research involving human subjects is required;

• Effective organizational, communication, and project team skills;

• Experience in developing and /or implementing Clinical Research SOPs in an industry setting;

• Medical affairs experience in medical device company preference.

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。