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Job Information

Philips Clinical Trial Manager in Beijing, China

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In this role, you have the opportunity to

  • Plan, Lead and be responsible for the Delivery clinical trials to timeline, cost, and quality from study protocol in compliance with GCP/SOPs, local regulations and the Clinical Study Protocol under supervision of line management with a certain degree of independence

  • Responsible for feasibility study at project level, ensure the feasibility truly reflected by analyzing information collected from each site.

  • Provide co-monitoring to CRAs to ensure study quality.

  • Develop and maintain excellent working relationships with external and internal customers, and selected CRO vendors to ensure the smoothly and timely delivery of clinical studies

You are responsible for

  • Clinical Trial Budget, Timeline, quality control planning.

  • Trial Essential documents preparation such as Protocol, CRF, ICF draft/finalization coordination.

  • Participates in the identification of potential investigators and clinical sites conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.

  • Participates in negotiating site/investigator grant within trial specific budget

  • Co-Conducts clinical site initiation visits; advises and trains site personnel on Philips internal and regulatory requirements for clinical trial conduct; participates and/or conducts site meetings

  • Co-erifies that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.

  • Co-Verifies that site facilities, including laboratories and equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.

  • Responsible for trial materials distribution and accountability coordination.

  • Oversee and reports trial progress and ensures timely subject recruitment and trial completion.

  • Oversee the site monitoring visits and follow-up to ensure that all clinical aspects of studies are being carried out in accordance with the protocol, regulatory requirements, GCP guidelines and SOPs.

  • Identifies trial site problems and initiates/implements corrective actions with the site monitors.

  • Ensures high quality CRF/EDC completion in a timely manner and performs source data verification

  • Ensures that the receipt, use and return of the investigational product(s) at the trial sites are controlled and documented adequately

  • Performs trial document management and ensures both trial / site specified TMFs and Investigator Folders are completed according to CFDA GCP, ISO14155, ICH GCP and internal SOPs.

  • Ensures all SAEs are appropriately reported within the time frame required by GCP, the protocol and the SOPs.

  • Ensures that the monitoring visit reports after each trial-site visit or trial related communication done by the site monitors.

  • Ensures the investigator payments are processed according to study site budget plan and clinical trial agreement with the investigator.

  • Performs miscellaneous job-related duties as assigned.

You are a part of

Great china Q&R team

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

  • Experience in clinical trial project management, even as a Sr. Clinical Research Associate/Specialist

  • Bachelor’s degree in clinical medicine or a life/biological science

  • Above 4 years clinical operation experience in Medical Device/Pharmaceutical corporate or CRO (Clinical Research Organization)

  • Familiar with GCP and relevant local regulations

  • Good command of spoken and written English

  • Good self-motivation and self-organization

  • Good interpersonal skills, diplomacy and the ability to motivate and organize other

  • Computer literacy essential

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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