北京招聘

Purpose of Job
Accountable for the study start-up timelines and delivery, with high quality and according to ICH/GCP
Major Responsibilities
Delivery of clinical start-up component of assigned studies with accountability for time, cost and quality for assigned activities, which include, but not limited to,
o Investigator/Site identification, including conduct feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study
o Prepare IRB submission
o Clinical trial site contract and budget negotiation, if required
o Prepare, submit regulatory documents to HGRAC and obtain approval for required study
? Assist in maintain and update company-level investigator database
? Establish, maintain and enhance relationship with key opinion investigators and sites
? Proactively identify potential issues and seek improvement. Take initiative for issue resolution within and outside start-up team. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans
? Perform other duties as assigned by management
职位要求：
Qualification
Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
? Knowledgeable in the execution of clinical trials, understanding of GCP/ICH Guidelines and other applicable regulatory requirements
? At least 3 year of clinical research experience in the Pharmaceutical or CRO industry
? Self-motivation with the ability to work under pressure to meet deadlines
? Fluent in English (writing and speaking)

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。