Job Description

Position name: Project Manager, Overseas Clinical Trials
Reports to: VP, Head of Clinical Operations
Department: Clinical Medicine
Location: Shanghai

一、KEY RESPONSIBILITIES：

1. Serves as an operational leader for clinical study teams

2. Ensures that clinical trials are carried out in accordance with ICG-GCP, local regulations, and Sponsor or delegated agent SOPs.

二、JOB REQUIREMENTS：

1. 1. Responsible for driving cross-functional alignment to strategic plans and goals;

2. Ensures that cost, time, and quality parameters are clearly outlined in the plans;

3. Communicates and collaborates with study team members, including but not limited to: Statisticians, Medical Managers, Data Managers, Safety Associates, Medical Writers;

4. Manages key documents and ensure they are kept current and accessible: ICFs, clinical trial implementation plan, monitoring plan, risk management plan, and various types of committee work plans;

5. Ensures and facilitates the completion of relevant documents, including but not limited to: Statistical Analysis Plan (SAP), Data Management Plan (DMP), Safety Management Plan (SMP), etc.;

6. Conducts relevant training to members of the study team;

7. Responsible for the management of CROs and vendors;

8. Coordinates site selection and maintains a good relationship with the selection of clinical trial research sites;

9. Responsible for coordinating the application of clinical trial sample collection to ensure that it is in accordance with the requirements of the regulations and research centers;

10. Responsible for coordinating study team meetings and/ or supporting CRA site start-up, as well as maintaining good communication with research sites;

11. Responsible for tracking the overall progress of the trial, the progress and quality of data collection, reviewing the CRA monitoring report, and working with the research team to conduct regular monitoring;

12. Assesses the risks and follows-up with the monitoring of study sites;

13. At the end of the clinical trial, coordinates the closure of site(s), including but not limited to drug recovery, final quality verification, archiving of all documents, and supporting the write-up of the study;

14. Establishes and manages clinical trial documentation based on ICH-GCP and Sponsor SOP requirements, if applicable

三、COMPETENCY REQUIREMENTS：

1. Ability to quality-manage clinical trials

2. Has good leadership and execution skills

3. Good English communication skills (written and verbal); at least English level CET6

4. Ability to work independently, but at the same time has a good sense of teamwork

5. Ability to problem-solve and risk-manage

6. Ability to adapt under pressure

四、SKILL REQUIREMENTS：

1. Solid knowledge of the overall drug development process and local regulatory requirements

2. Familiar with ICH-GCP guidance

3. Ability to present and provide study updates to external and internal stakeholders

4. Can independently access relevant literature

5. Basic knowledge of computer skills and Office software applications.

6. DESIRABLE BACKGROUND:

（1） Education requirement: Bachelor’s degree or above

（2） Professional requirements: Medicine, health, pharmaceutical or CRO experience

（3） Work experience: At least 5 years of work experience with at least 2 years in clinical trial management。

上班地址：上海