广州招聘

PRIMARY FUNCTION

Act as principal link between the investigator and HMP for trial management, esp. on-site monitoring

MAJOR RESPONSIBILITIES AND DUTIES

Site management for assigned trial

Be familiar with trial execution process of assigned trial

Be responsible for following activities:

• Site selection
• Prepare Site specific documents include but not limit to EC presentation slide, GCP office require documents, Inform Consent, study contract, site drug management manual, subject management matrix etc.
• Site initiation
• Site monitoring based on applicable monitor plan
• Site close out visit
• Key personnel to coordinate with trial specific vendors to complete the trial related activities.
• Complete all trial related report within SOP defined timeline

1. Site master file and investigator file management
2. Deliver trial related training to site staffs
3. Update site status to project manager at timely manner
4. Prepare all required report to line manager at timely manner

Qualifications

• At least 2 year clinical trial on site management experience
• At least bachelor degree in Clinical Medicine or Pharmacy or related major
• Good communication skill and team player
• Good command of computer skill
• Adequate verbal and written communication skills in English

Internal-External Relations

Internal: staffs within C&R department

External: Investigators and other relevant persons in hospitals or institutes

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。