苏州招聘

The job of the Sr. Clinical Affairs Specialist is to oversee the progress of the clinical trial on the individual site basis and to ensure that it is conducted in accordance with the protocol, regulatory requirements, good clinical practice and standard operating procedures.

The Sr. Clinical Affairs Specialist will be acting as the trial site manager and the main line of communication between Philips, selected CRO vendors and the site investigators.


Responsibilities

· 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

· 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

· Verifies that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.

· 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

· Monitors and reports trial progress and ensures timely subject recruitment and trial completion.

· Conducts 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.

· 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.

· Complete a written monitoring visit report after each trial-site visit or trial related communication. Report should include a summary of what the monitor reviewed and the monitor’s statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.

· 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.


Knowledge and skills required

· Bachelor's degree in the fields of Healthcare Sciences plus minimum 2 years of working experience and in which at least 1 year Clinical Trial relevant working experience.

· Knowledge of GCP and understanding of national regulations essential

· Good self-motivation and self-organization

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

· Fluency in both verbal and written English essential

· 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。