Skip to main content

CTM

Location Shanghai, 上海, 中国 Job Id R-01303559 Job Type 全职 Category 临床研究 Remote 混合办公
返回搜索结果
上一份工作 下一个工作
JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
• Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
• Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
• May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees.
• May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

Close the popup
伊姆格1

我们将确保为残障人士提供合理的便利服务，使其可以参与求职或面试、履行基本的工作职能，以及享有其他就业福利和优待。如需任何便利服务，请与我们联系。
​​​​​​​ 
了解更多

获得类似职位的通知

注册以便您可以通过电子邮件接收类似工作职位提醒

成功！您成功订阅类似职位提醒 失败！你已订阅过此职位提醒 失败！未能订阅类似职位提醒

类似工作

  • CTM

    职位Id R-01211806

    Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the...

  • ACTM

    地点 Shanghai, 上海, 中国 职位Id R-01281110

    Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the...

  • Project Mgr

    职位Id R-01223851

    On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendo...

  • Trial Activation Approval Specialist III

    地点 Shanghai, 上海, 中国 职位Id R-01300333

    Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submiss...

  • CTA

    职位Id R-01223852

    Performs administrative tasks including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as...

  • Drug Safety Operations Specialist

    地点 Shanghai, 上海, 中国 职位Id R-01311375

    Support the development and implementation of essential processes, systems, and tools for managing local PV activities according to assigned duties. Where applicable, support review of protocols for l...

  • CRA (Level II)

    职位Id R-01211804

    Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conducts site visits to assess protocol...

  • CRA (Level II)

    职位Id R-01222716

    Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights,...

  • CRA (Level II)

    职位Id R-01227596

    Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights,...

未找到推荐

求职者还看了

未找到推荐

求职网站 Cookie 设置
个人信息