长沙招聘

Job Description-Clinical Quality Manager

In this role, you have the opportunity to

• project tracking and completion, to all internal and external stakeholders;

  You are responsible for

  • Implement the GCP quality strategies to ensure all QA/QC and audit activities for clinical studies are according to risk management plan to ensure the clinical study can withstand audit scrutiny by internal audit or regulatory health authority; Manage the inspection readiness activities and participate in managing regulatory health authority inspections;

  • Lead and manage GCP Quality investigations to ensure all the company-sponsored studies executed in compliance with GCP, related regulations, Philips clinical SOPs in terms of quality and timeframe;

  • Ensure all necessary SOPs for clinical study activities related to GCP are developed, up-to-date, and well executed;

  • Support the implementation and maintaining key GCP QA systems, such as; Investigations, Deviations, CAPAs, Audits, developing and managing integrated risk management plan;

  • Defining metrics and measures for GCP Quality Assurance to drive assessment and continuous improvement to clinical study;

  • Support in reviewing, revising and implementing of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, EC submission modules, etc.

  • Participate in the review of study related metrics (i.e.; protocol deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements.

  • 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 QMRP as well as SOP 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.

     

    You are a part of

    Great China Q&R team

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

  • At least 7 years’ experiences in clinical research execution, including at least 2 years’ QA/QC, audit and quality risk management experience;

  • Self-motivated individual who is able to manage multiple tasks and priorities in an efficient manner.

  • Demonstrated track record of Compliance to regulations governing human clinical research.

  • Demonstrated expertise of GCP and related regulatory requirements for the conduct of research involving human subjects is required.

  • Effective communication and project team skills.

  • Comfortable working closely with a team taking ownership/initiative where needed, and taking/delegating task appropriately.

  • Total Clinical Study Management, QA/QC, audit and CAPA resolved experience is required.

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。