POSITION SUMMARY（职位概述）

The position holder needs to work closely with both internal key stakeholders (RA, MA, GCD, R&D) and external stakeholders (CRO, SMO, PI) to manage BD sponsored clinical trial projects, ensuring on time delivery with good quality control, maintaining high standard compliance in the meantime.

KEY RESPONSIBILITIES（主要职责）

1. Participate in and contribute to the development of clinical trial plan, protocol, CRF, study report

2. Develop project management plan & site monitoring plan.

3. Participate in vendor selection and provide constructive inputs

4. Oversee all project related procedures, including but not limited to site selection, investigator meeting, site initiation, patients enrollment, site monitoring and closure etc.

5. Ensure project quality, timeline and budget under control and meet BD requirements.

6. Oversee CRO performance, to make sure the delivered results meet BD requirements.

7. Provide leadership to study team during problem solving and risk management.

8. Ensure project is performed, recorded and reported in accordance with protocols, SOPs, GCPs and other applicable regulation requirements.

9. Coordinate internal and external resources and effective communicate with internal and external stakeholders during trial execution.

10. Maintain good relationship with key investigators

11. Maintain high standard compliance during the entire process

SKILLS AND ABILITIES（技能）

1. Bachelor’s Degree is required;

2. 5-year experience in clinical research with a minimum of 2-year experience of project management

3. Medical Device clinical operation experience is preferred;

4. Medical, Biology education or working experience background is preferred;

5. Demonstrated good knowledge of the NMPA regulations, ICH-GCP;

6. Good planning, organizing, team-work, leadership and communication skills;

7. Fluent skills in both spoken and written English

DESIRABLE（优先条件）

1. Experience of Class III products for endo-vascular therapies (e.g. stents), surgery registration clinical trials

2. Experience of NMPA inspection and audit;

3. Experience engaging and interacting with CMDE

Working conditions & environment(工作状况和条件):

(如是否需要经常出差? Home based?)

1. Business travel required. 30%

上班地址：上海