Scope of responsibilities:

1. Operate and manage the clinical data team;

2. Monitor and follow the activities of data management throughout clinical trials and quality control, review the data on a regular basis, record, follow, communicate and solve the problems or risks discovered;

3. Provide advice on clinical trial protocols from a data management perspective;

4. Write or review documents for data management, including data management plans, data verification plans, CRF completion guidelines, external data transfer protocols, SAE consistency plans, data management reports，assist in finalizing CRFs and CRF audits;

5. Help to build databases, responsible for user acceptance testing （UAT） of databases and verification procedures;

6. Help to develop and improve the quality management system documentation for the DM department;

7. Formulate annual department development plans based on company planning and strategies;

8. According to business needs, advance the building and cultivation for clinical data team, regularly organize and perform trainings for the department.

Requirements:

1. Bachelor’s degree or higher in Medicine, Pharmacy, Life Sciences, Computer Science and other relevant fields;

2. Over 5 years of experience in clinical trial data management and over 1 year of experience in team management;

3. Familiar with Rave EDC system;

4. Familiar with laws and regulations related to clinical trials and clinical trial data management, including ICH-GCP and GCDMP;

5. Familiar with CDISC and SDTM standards and medical code dictionaries including MedDRA and WHO Drug;

6. Good communication skills both in Chinese and English, proficient skills in office software;

7. Strong sense of responsibility and proficient team management skills;

8. Ability to communicate, coordinate, organize, lead a team and work under pressure.