Posted on Oct 12th 2019

Clinical Operation Manager

中国,上海,上海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,上海,上海

Full time

374126

保存职位

Job Title

Clinical Operation Manager

Job Description

In this role, you have the opportunity to

  • Lead the team to ensure all the company-sponsored studies executed in compliance with GCP, related regulations, Philips harmonized clinical SOPs in terms of quality and timeframe.
  • Ensure robust and complete clinical plans are developed; the consistent and effective communication of clinical plans, project tracking and completion, to all internal and external stakeholders;
  • Manage Contract Research Organization oversight, including staff; coordination of site visits, review reports and ensure adequate corrective action;
    Ensure that all study staff are appropriately qualified and trained to execute research project per protocol, clinical SOPs and GCP;
  • Provide leadership in standardizing and optimizing clinical-related materials to Ethics Committee.

You are responsible for

  • the best practice of operational execution in the conduct of clinical study for the purpose of validating product Safety and Efficacy for pre-market approval, claims substantiation and/or to fulfill post-market requirements, when applicable.
  • 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 Affairs management team and 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
  • Coordinates and streamlines the clinical research workflow in order to support the clinical deliverable.
  • Obtains approval to conduct clinical trials of investigational equipment.
  • 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 Clinical team, reporting to Head of Regulatory, Clinical & Medical Affairs-GC

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

  • Bachelor’s or Advanced Degree in Medicine or life science education background
  • At least 10 years’ experiences in clinical development and/or medical affairs of pharmaceuticals and/or medical device industry
  • At least 3 years ’people management experience
  • Demonstrated track record of Compliance to regulations governing human clinical research.
  • Demonstrated expertise of GCP and CFDA regulatory requirements 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
  • Total Site Management, Budgeting, Agreement negotiation experience is required.
  • Must be able to interpret complex Clinical Trial Datasets.
  • Must have a demonstrated track record of working with diverse platforms of Data Collection.

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.

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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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