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Philips Clinical Trial Senior Specialist in Shanghai, China

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In this role, you have the opportunity to

  • Broadly defined, this role is responsible for the operational execution of clinical study involving human subjects from its inception to close-out.

  • 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;

  • Develop Clinical Evaluation Report (CER) per needs.

You are responsible for

  • 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).

  • Provide leadership in standardizing and optimizing clinical-related materials to Ethics Committee;

  • Develop Clinical Evaluation Report (CER) per needs.

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 4 years’ experiences in clinical research execution, including at least 1 years project 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 CFDA 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 Site Management, Budgeting, Agreement negotiation experience is 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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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