Job TitleSenior Clinical Operation Specialist
In this role, you have the opportunity to
Ensure clinical study successfully complete on time, on budget, in high quality and compliance with regulatory requirement.
You are responsible for
- Ensure all the clinical 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 can withstand audit scrutiny by internal clinical trial audit or Regulatory entity where the risk of failure can affect product registration;
- Assists 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;
- Manage Contract Research Organization oversight, including staff; coordination of site visits, review reports and ensure adequate corrective action;
- Independently prepares high quality clinical trial execution, study essential documentation and project management.
- 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).
- Satisfaction level from NMPA for clinical evaluation report and clinical trial documentation or data;
- 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
- Bachelor’s or Advanced Degree in Medicine or life science education background
- At least 2 years’ experiences in clinical research execution, including at least 2 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.
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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