长沙招聘

职位描述：
Job description
Sr. Clinical Research Specialist

Your challenge
Your challenges are to use your clinical research skills to develop and deliver clinical evidence to internal & external stakeholders to further innovation & optimize product life-cycle with flawless execution.
Your responsibilities
As a Sr. Clinical Research Specialist you are responsible for:
? Site Monitoring & Management:
o Manage study activities at assigned investigational sites.
o Verify the quality of the investigator and the suitability of the sites by performing study feasibility or site evaluation visit to ensure the site is qualified and suitable to conduct the study.
o Re involved in the preparation of the documentation for submission to EC.
o Ensure the smooth negotiation process on the site contract sign-off. Be responsible for site payment is properly paid according to the agreement.
o Perform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations and ICH GCP. Prepare and submit accurate and timely site visit reports for all performed visits.
o Keep and maintenance the TMF and SRF to ensure it is up to date, complete and accurate according to company SOPs, regulations and ICH GCP.
o Verify the accuracy, completeness and legibility of the data collected in the studies;
o Ensure all case report forms can be collected and queries can be resolved in timely manner;
o Ensure all adverse events occurred in the study be reported in compliance with study as well as regulation requirement;
o Verify the trial supply is stored, transferred and tracked appropriately. And unused investigational product and other study supplies is returned or destroyed properly after the completion of study.
o Assist in the preparation for the internal or external audit/ inspection. Resolve issues cited in audit reports.

? Project Management
o Set up and lead the project team to ensure the study is implemented according to company policy, SOPs and relative regulations.
o Prepare the study request form and coordinate the protocol and other study documents development and approval process;
o Lead the project team to accomplish the proposed timeline;
o Communicate with internal and external business partner in terms of project progress and outstanding issues;
o Evaluate the potential investigational sits for a specific study in terms of the qualification of the investigator and the suitability of the sites;
o Evaluate the CRO, provide evaluation assessment to line manager;
o Actively guide and coach CRAs in the study team;
o Coordinate with Data Management, Statistician and Medical Writer to ensure the deliverable on time.

? Vendor Management
o Perform vendor selection and continuous quality and compliance tracking and evaluation;
o Perform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with Philips policy, SOP and other related requirements.

Your team
You will report directly into the Sr. Manager, Clinical & Scientific Affairs-China. Clinical & Scientific Affairs China team is part of Global Clinical Affairs team, work closely with Greater China Q&R team to support the China product registration via generating the clinical evidence. You will have close interaction with Global/BU clinical team, China Regulatory affairs and other cross-functional team as well as key opinion leaders and investigators.
Our offer
We offer you the opportunity to work on delivering the evidence and growing the people who contribute to it. Join us and you can provide your deep insights that accelerate innovation and drive value and safety for patients and customers everywhere.

We are looking for
? Bachelor’s degree & above, clinical medicine or life science preferred.
? Minimum of 3 years’ experience in a pharmaceutical or medical device company for clinical research execution, including at least 1 year project management experience.
? Site assessment/monitoring experience is required
? Be able to collaborate effectively with the Clinical Operations team, cross-functional team members, and external partners
? Demonstrated communication / interpersonal skill (oral and written).
? Fluent in English reading & writing
? Self-motivated individual who is able to manage multiple tasks and priorities in an efficient manner
? Proactive attitude
? Conscientious and precise delivery of work even when under pressure 举报 分享

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。