长沙招聘

Scientific Affairs Manager

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

• 30-50% travel required

荷兰皇家飞利浦公司是一家领先的健康科技公司，致力于在从健康生活方式、疾病预防、到诊断、治疗和家庭护理的整个“健康关护全程”，凭借先进的技术、丰富的临床经验和深刻的消费者洞察，不断推出整合的创新解决方案，助力健康医疗系统实现四重目标——提高大众健康水平、提高医护人员满意度、改善患者体验，并降低关护成本。飞利浦的愿景是通过有意义的创新，令世界更健康、更可持续的发展，到2030年每年改善25亿人的生活。

        飞利浦公司总部位于荷兰，2021年销售额达172亿欧元，在全球拥有大约78,000名员工，销售和服务遍布世界100多个国家。公司目前在诊断影像、图像引导治疗、病人监护、医疗信息化以及消费者健康和家庭护理领域处于领导地位。

        在飞利浦，每一个人，都至关重要。这是我们始终坚持的信念。在飞利浦，你将用数字化驱动有意义的创新，积极影响自己与数十亿人的生活，践行改善人类生活的使命。我们全心营造多元包容的工作环境，平等互助的工作氛围，让你的独特之处得到充分尊重和欣赏，鼓励你释放真我，以梦为马，不负韶华。本着 “立足中国，辐射全球” 的理念，我们通过布局广泛的业务线，为你带来广阔的平台、丰富的学习资源、多样的内部发展机会，助你成为具备全球化视野和本土深度的一专多能复合型稀缺人才。

创美好，做真我，迎蜕变。
我们深信每一个你都卓尔不凡, 更期待与志同道合的你笃行致远。