Senior Clinical Trial Associate
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000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:2019-11-16
- 工作地点:上海
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:招1人
- 语言要求:不限
- 职位类别:生物工程/生物制药
职位描述
? Assist CRA to prepare EC submission dossier & PDFA submission according to site requirements and regulations. Check document for quality consistency if needed.
? Distribute site supplies such as equipment, ISF including essential document, stationery and other printed material. Liaison with vendors for shipment and tracking. Liaison with vendor and CRA to provide calibration, exchange and retrieval of site equipment.
? Coordinate site contract signature and payment process, track and follow up the payment progress and invoices retrieval with SSU/CRA.
? Support CRA submit the study SUSAR/SAE and other essential documents to sites according to site or study requirements.
? Assist archive some required documents to eTMF as study/country required timeline, follow with SSU/CRA to ensure the document completeness.
? May have other dedicated tasks to meet the needs of study teams and/or fulfill country specific requirements with the agreement of line manager.
? May need to provide the office admin support to local office colleagues, such as Onboarding and Off-boarding employees process, SharePoint maintenance, dept. meeting/training support.
? Assists country team in development and management of centralized local operational processes to support clinical trial conduct in China in compliance with Good Clinical Practice, applicable regulatory and company requirements.
? The responsibilities may be adjusted according to the needs of the study or business.
职位要求:
? Bachelor’s Degree with 0~1year relevant experience in Pharmaceutical or CRO industry
? Excellent organizational skills and ability to prioritize and multi task
? Fluent in English (writing)
? Distribute site supplies such as equipment, ISF including essential document, stationery and other printed material. Liaison with vendors for shipment and tracking. Liaison with vendor and CRA to provide calibration, exchange and retrieval of site equipment.
? Coordinate site contract signature and payment process, track and follow up the payment progress and invoices retrieval with SSU/CRA.
? Support CRA submit the study SUSAR/SAE and other essential documents to sites according to site or study requirements.
? Assist archive some required documents to eTMF as study/country required timeline, follow with SSU/CRA to ensure the document completeness.
? May have other dedicated tasks to meet the needs of study teams and/or fulfill country specific requirements with the agreement of line manager.
? May need to provide the office admin support to local office colleagues, such as Onboarding and Off-boarding employees process, SharePoint maintenance, dept. meeting/training support.
? Assists country team in development and management of centralized local operational processes to support clinical trial conduct in China in compliance with Good Clinical Practice, applicable regulatory and company requirements.
? The responsibilities may be adjusted according to the needs of the study or business.
职位要求:
? Bachelor’s Degree with 0~1year relevant experience in Pharmaceutical or CRO industry
? Excellent organizational skills and ability to prioritize and multi task
? Fluent in English (writing)
职能类别:生物工程/生物制药
公司介绍
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。
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)