鹰潭招聘

工作描述/ Brief description of service :

1.Manage study sites for regulated and/or post-market studies to ensure successful conduct of clinical projects in accordance with established SOPs, policies of Zimmer Biomet and local regulations, which includes prepare for study start up activities (e.g. ethics committee submission, HGRAC submission, contract negotiation and execution, etc.), perform site qualification, initiation, interim monitoring and close-out monitoring visits, evaluate the performance/compliance levels of site and take appropriate action necessary to resolve any issues of noncompliance, manage site budget, process payments and maintain clinical trial files.

2.Support the development of project budgets, annual operating budget, project needs assessments and clinical study plan. Discuss with stakeholders and obtain the necessary approvals from relevant review committees on clinical projects.

3.Support the design and development of clinical study documents (e.g. study protocol, case report form, informed consent forms and monitoring plans, etc.);

4. Participate, plan, and help lead study trainings (e.g. investigator/coordinator meetings, site initiation visits, internal study team training).

5.Support Project lead to review and provide input to improve clinical operations efficiency. Implement and track relevant key performance indicators to assess the performance of clinical operations and ensure the deliverables from the clinical projects are met in accordance to the agreed plan.

6.Serve as technical and scientific resource to study site staff, investigators, sales representatives, and other staff members regarding investigational products and protocol.

岗位要求/Skills and qualifications required:

1.A bachelor’s degree in the health, life sciences, engineering or related disciplines.

2.Minimum of 1-2 years of clinical research experience (preferably in device trials/studies) in China.

3.Thorough knowledge of international guidelines and local regulations in the conduct of clinical research especially in medical devices.

4.Knowledge in clinical research methodology and processes from the set up to completion phase of clinical research projects.

5.Good technical knowledge in the field of orthopedics and orthopedic implants is advantageous.

6.Capable of clearly and effectively communicating verbally and in writing.

1.健康、生物、生命科学、工程学或相关学科的学士学位。

2.至少1-2年临床研究经验（***是设备试验/研究）。

3.全面了解临床研究的国际准则和地方法规，尤其是医疗器械方面的知识。

4.了解临床研究方法和过程，从临床研究项目的建立到完成阶段。

5.在骨科和骨科植入物领域有良好的技术知识是加分。

6.能够清晰有效地进行口头和书面交流 。

7.医疗行业优先，或者IVD背景，生物专业也可考虑。