职位描述

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 coordinationParticipates 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 budgetCo-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 meetingsCo-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 SOPIdentifies trial site problems and initiates/implements corrective actions with the site monitorEnsures high quality CRF/EDC completion in a timely manner and performs source data verificatio Ensures that the receipt, use and return of the investigational product(s) at the trial sites are controlled and documented adequatelyPerforms 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. 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/SpecialistBachelor’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-organizationGood interpersonal skills, diplomacy and the ability to motivate and organize otherComputer literacy essential30-50% travel required In return, we offer you A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this 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. Our benefits are very competitive and designed around your preferences: We offer a market conform salaryA variable bonus based on both Philips results and personal performanceConvenient working conditions in officeExtensive set of tools to drive your career, such as a personal development budget, free training and coachingAttractive collective health insurance packageOpportunity to buy Philips products with discountHealthy work-life balance 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. 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. 职能类别： 临床研究员 其他 关键字： Clinical Trial

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