上海招聘

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.

岸迈生物是一家创新型国际化生物技术企业，在上海和苏州分别设有研发中心和中试基地，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技术平台能够通过分子生物学手段将两个单抗序列糅合在一起形成一种结构独特的双特异性抗体，是全球***的既不需要任何氨基酸突变、也不包含连接肽链及任何非抗体序列的双特异性抗体技术，具备很高的成药性和产业化效率。基于FIT-Ig平台技术，岸迈生物正在针对肿瘤免疫和其他临床需求高的领域进行双特异性抗体系列原创产品的开发。岸迈生物同时也在通过全球范围内的技术授权、合作开发等多种形式实现平台的战略发展和产品多元化布局。
公司网页：**************
简历投递：hr@epimab.com
About EpimAb Biotherapeutic
EpimAb Biotherapeutics is a privately-owned biopharmaceutical R&D company based in Shanghai？ with a proprietary unique and efficient technology called FIT-Ig (Fabs-In-Tandem Immunoglobulin) to generate bispecific molecules with antibody-like properties， without any mutations, peptide linkers, or non-Ig sequences. With this platform, EpimAb is creating a pipeline of its own novel bispecific antibody therapeutics focused around immuno-oncology and other areas of high value to patients. EpimAb is also committed to diversifying its pipeline through selective licensing of its platform to partners worldwide. For further information, please visit **************
Web:**************
Email:hr@epimab.com