临床研究项目经理
上海德琪医药科技有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-01-12
- 工作地点:北京
- 招聘人数:2人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:2-5万/月
- 职位类别:生物工程/生物制药
职位描述
Job Purpose: Responsible for project timeline and project budget, and oversees the key deliverables, project milestones for Antengene’s ongoing clinical trials.
- Very familiar with study protocols, CRF, ICF, lab manual, pharmacy manual, clinical monitoring plan
- Very familiar with site and submissions for ICH-GCP, site contract process and governor approval
- Contribute to PI and site identification, communications, and initiation
- Contribute to site feasibility process
- Prepare for weekly project meeting based on agenda, project status and pending issues.
- Set up TC and drive the meeting
- Review protocol, ICF and eCRF amendment in collaboration with the team
- Help identify CROs and negotiate budgets
- Review and approve invoice.
- Review site monitoring reports and follow up with CRO to resolve issues
- Follow up insurance status during different stages of the trials.
- Collaboration with internal supply chain & IP vendors on IP storage and shipment procedures.
Qualification
- Education : Medical, Pharmacy, Biology, and Immunology department, bachelor or above
- Excellent English, especially fluent Oral English
- At least 1 years of experience in Clinical Project Management International clinical project management experience is preferred
- Oncology project management experience is preferred
- Strong communication skills and coordination skills
- Excellent problem solving
职能类别:生物工程/生物制药
公司介绍
德琪医药有限公司(简称“德琪医药”,香港联交所股票代码:6996. HK)是一家专注于创新抗肿瘤药物的亚太地区临床阶段生物制药公司,德琪医药旨在为亚太地区及全球各地的患者提供全新作用机制的抗肿瘤创新疗法。自成立以来,德琪医药已建立起拥有12款临床及临床前创新药物的丰富产品管线,取得9个临床批件,并在亚太地区开展9项跨区域临床试验。公司在研产品专注于创新的靶点或作用机制,并拥有成为同类首款潜力的药物。德琪人以“医者无疆,创新永续”为愿景,力争通过对全球***和同类最优的专研与市场化,解决亚太乃至全球患者未满足的临床需求。
联系方式
- Email:Peter.Qian@antengene.com
- 公司地址:上海市长宁区中山西路1065号 中山SOHO 广场B 座 (邮编:200051)