清远招聘

PRIMARY DUTIES:

• Management of clinical research project
• Vendor (CRO, Lab, drug storage, etc.) supervision and management
• Liaison with KOLs
• Support IND and NDA filing
• Quality control of the clinical research projects, such as co-monitoring

 

RESPONSIBILITIES:

• Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
• Provide leadership in the conduct of clinical trials, protocol implementation, data analysis, management of project progress and timelines.
• Input operational part of the protocol for trials.
• Review and approve study CRFs.
• Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
• Contact with CMC department regarding design of labeling, packaging and drug logistics.
• Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
• Select clinical trial site and keep good relationship with investigators.
• Initiate and ensure timely submission to IRB/IEC and support investigator as necessary.
• Support contract negotiation with study sites.
• Select and cooperate with statistician to conduct data analysis when required.
• Participate in regular Data Quality Review Meetings.
• Coordinate final trial report.
• Support CRO Selection.
• CRO supervision at the trial level.
• Support IND and NDA filing: Document review and progress tracking.
• Do co-monitoring visits for the project.
• Review monitoring reports.
• Check TMF before archiving.

 

QUALIFICATIONS:

• At least bachelor degree in pharmacy, biochemistry or related major. Mater degree is preferred.
• 5-8 years industry experience with proven proficiency in clinical research management for drug development.
• Good understanding of ICH guidelines, GCP and regulatory requirements.
• Excellent planning, organization and problem solving abilities.
• Good communication and interpersonal skills.
• Proficiency in English and familiarity with standard IT office tools.

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。