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 .