Accountability：

一、Quality control of clinical trial

1. Establish communication with global quality management team, develop and maintain clinical trial quality control system in line with global new standard and procedure, such as study risk based monitoring

2. Review clinical study documents and conduct co-monitoring according to company requirement.

3. Develop verification process that will allow identification of abnormalities / inconsistencies.

4. Suggest how to improve the quality based on the current clinical trials situation.

二、SOP development /maintenance

1. Join global SOPs development and update, harmonize local SOPs with global SOPs, ensure local standards and procedures are consolidated with global SOPs

2. Develop and update SOP according to related laws, regulations and company requirement.

三、Training of ACN DD / CRO CRAs and relevant members

1. Develop and maintain training system, provide training to new and existing staff to ensure their qualification

2. Provide training based on the inspection / audit results

3. provide training according to GCP and company policy

4. Provide training of Chinese clinical trials related regulations

四、Supports of inspection/audit conducted by health authority/internal auditor

1. Take note to new local regulations and industry standards, such as new GCP, self inspection requirement etc., communicate with global team and industry organizations to assess the impact to clinical operation

2. Support and ensure inspection/audit readiness, appropriate conduct and follow up, serve as the primary liaison with QA/inspectors to control the activities during inspection/audit

3. Arrange the audit with ACN DD members based on internal CQA/health authority request.

4. Support document preparation for Audit

5. Draft / review the response to audit report (eg CAPA)

6. Follow up CAPA

五、People management

1. Coach and provide training to improve the QC staff’s ability

2. Understand the QC staff’s career development expectation and retain excellent talent for the company

Qualifications：

一、Education

1. Master/Bachelor

二、Skills

1. Demonstrated communication, negotiation/influencing, and social skills with a sense of diplomacy, relating to peers.

2. Very good active and passive skills in English, leading and attending meetings, presenting and training.

3. Working knowledge of China drug development processes.

4. Understanding the impact of regulatory requirements and guidances / internal SOPs / PM concepts.

5. Works effectively under pressure, accurate and patient.

6. Proficient in utilizing and creating outputs using relevant software. Easily adapts to change.

三、Experience

1. 5 years or above CRA project management experience

2. at least 3 years quality management related experience

3. knowledge of medicine or pharmacy

4. have team spirit, relevant computer skills and organizational training skills

上班地址：建国门外大街8号IFC大厦