临床运营高级经理/副总监/总监

上海岸迈生物科技有限公司

浦东新区-张江镇 | 不限工作经验 | 硕士

2020-09-16发布

招聘人数:1人

30-40万/年

申请职位

职位信息

Job Summary: This role will be responsible for the first in human new compound phase 1 trial management. This role is accountability for the study end to end delivery throughout study design, start-up, conduct, analysis and reporting, study site close-out. Responsibility: Job description: 1.Ensure clinical trial deliverables are met according to timelines, budget, operational procedures, and quality standards adhere to current regulatory guidance and GCPs. 2.Manage aspects of trial operations, including vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the project team. 3.Manages the negotiation of contracts, budgets and timelines with CROs, clinical sites, and other external partners. 4.Manage activities associated with study start-up, conduct and closeout activities to industry and corporate standards and goals. 5.Contribute to the writing and review of study conduct related documents such as monitoring plans, CCGs, lab manual and pharmacy manual etc. 6.Review study invoices and manage accruals monthly. 7.Ensure Trial Master File documentation is collected and completed contemporaneously. Qualifications: 1.Bachelor’s level degree or above in life sciences, pharmacy, medical or related specialty including nursing and other biological background. 2.Minimum 5 years of experience in clinical trials management in MNC or a biotech or CRO. 3.Demonstrated knowledge and understanding of FDA/NMPA/GCP/ICH regulations and guidelines. 4.Strong operational skills with detail oriented and demonstrate the ability to deliver quality results in a timely manner. 5.Ability to take initiative and work both independently and in a team environment. 6.Excellent verbal and written communication skills in English and Chinese. 7.Strong multi-tasking, time management, and organizational skills.

联系方式

上班地址:金科路4560号2号楼6楼

上海岸迈生物科技有限公司


•外资(非欧美)

• 50-150人

• 制药/生物工程

上海岸迈生物科技有限公司是位于上海浦东新区张江高科技园区的一家新兴的创新型国际化生物技术企业,专注于利用自主知识产权的双特异性抗体技术平台(FIT-Ig)进行创新生物药的研究和开发。FIT-Ig技术是一项新型的双特异性抗体的技术平台,该技术平台能够通过简单的分子生物学手段将两个抗体串联在一起形成双抗,该双抗同时具备了两个原始抗体的功能,拥有双重活性和产业化优势。基于FIT-Ig平台技术,岸迈生物目前拥有十几个自主开发的 First-in-class 生物大分子新药研发项目,专注于恶性肿瘤靶向治疗,肿瘤免疫,T细胞导向治疗等领域。FIT-Ig技术同时也吸引了国内外多个主流生物医药企业的关注,目前已经和包括信达生物、英国Kymab公司等在内的多家企业达成了技术与产品的合作,岸迈将通过技术授权、合作开发、共享收益等多种形式实现平台战略发展,为国内药企开发双抗药物起到了引领示范和带头作用。20179月,岸迈生物荣获2017年中国创新创业大赛(生物医药行业初创组)全国总决赛冠军。
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