大连招聘

1. As a team leader, works with internal functional areas or external vendors on assigned project delivering. Ensures the project is proceeded according to the BPI’s quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all applicable regulations.

2. Fully accountable for the project launch, conduct, and closeout according to predefined plan. Plans and projects resources required of assigned project. Oversees and carries out all necessary quality management activities to ensure deliverable of all involved functional.

3. Reviews project documents including but not limited to protocol and draft case report forms (CRFs) for consistency within each document. Develops and maintains project plans for the project in accordance with SOPs.

4. Liaises and facilitates cross functional or communication with external vendors for project related tasks and/or issues. Alerts senior management to potential issues and ensures necessary corrective action is taken.

5. Demonstrates working knowledge of current therapeutic environment and develops knowledge of drug development trends. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training.

6. Maintains effective communication with the internal and/or external project team through oral and written correspondence, project status reports, and monthly progress reports, and presentations. Ensures adequate documentation of each communication. Host and/or attends p clinical operation meetings, project team meetings, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans.

7. Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plans to appropriate team members and senior management.

8. Oversees TMF and the regulatory document collection and submission process.

9. Assists in the negotiation and contracting process with external vendors such as laboratories, EDC, IXRS etc..

任职要求：

BA/BS in the clinical medicine, nursing degree, or equivalent combination of education and experience. Appropriate knowledge on ICH, NMPA GCP guidelines and drug development process. Demonstrated proficiency with overall knowledge of clinical trial conduction in China especially, site start-up, clinical monitoring and site closure procedures. At least 6 years clinical research experience in a contract research organization, pharmaceutical, or biotechnology company. Previous Lead CRA equivalent experience. Oncology and relevant therapeutic experience preferred. Previous technical and managerial experience in conducting multi-national clinical trials preferred. Presentation, documentation, and interpersonal skills as well as a team-oriented approach. Proficient computer skills in Word, Excel, PowerPoint, email and Internet. Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. Good command of English in writing and speaking.

    大连万春布林医药有限公司是一家临床阶段的生物制药公司，专注于开发创新的免疫肿瘤抗癌疗法。集团公司万春药业已于2017年在美国纳斯达克成功上市。
    公司现阶段的核心产品为一类抗癌新药，该项目已有多项适应症进入全球三期临床尾声。