-
3-4年经验 -
本科 -
招1人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 员工旅游
- 交通补贴
- 年终奖金
- 餐饮补贴
- 通讯补贴
- 定期体检
- 专业培训
职位描述
职位描述： Job DescriptionTo manage the clinical trials in respiratory and other viral infection indications with specific focus on the technical (medical/scientific) input and operational coordination of clinical studies, with external experts, service providers, internal department and project teams.Key Responsibilities1. Serve as the primary point of contact for Sponsor.2. Management of all logistical and operational activities from study start-up through closeout, ensuring adherence to regulatory guidelines, company SOPs, study timelines and inspection readiness.3. Oversight and management of CRO and third-party vendors.4. Develop, communicate and evaluate trial management plans to include trial team objectives, workflows and timelines.5. Coordinate and collaborate with data managers, statisticians and any other trial team members.6. Coordinate, manage and document all trial team meetings, to include preparation and maintenance of agendas and meeting minutes.7. Develop and/or provide input and review on study related documents such as clinical monitoring plans, data management plans, protocols, informed consents, case report forms (CRF), CRF completion guidelines, EDC training guides clinical study reports, statistical analysis plans, site instructions for specimen collection, laboratory manuals, investigative site GCP and protocol training materials, investigator newsletters etc.8. Providing oversight and management for filing study records in the Trial Master File (TMF).9. Providing oversight, support and input to collect and maintain appropriate documentation for adverse event safety reporting and collaborating in the submission of safety reports to the FDA, IRBs/IECs and other applicable regulatory authorities.10. Development of recruitment strategies to increase patient enrollment.11. Developing tools for the provision, accountability and tracking of clinical trial materials such as Investigational Product (IP) and non-IP materials to investigative sites for the duration of the trial and ensuring site accountability records are maintained.12. Overseeing site initiation, interim monitoring and close-out visits as needed to include training materials used during visits.13. Responsible for the financial management of the clinical trial including budget planning and tracking, resource allocation and preparation of quarterly reports.14. Training and coaching of internal CRAs as required.15. Providing support and assistance to sites for audit and inspection readiness.Key Qualifications1. Doctorate, Masters or Bachelors degree. Major course of study must be science or health related.2. Three or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Pharmaceutical, or Biotechnology industry is required.3. Therapeutic experience in respiratory or infection disease (preferred)4. Read, write and speak fluent English; excellent verbal and written communication skills5. Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods. 职能类别： 医药技术研发管理人员 关键字： Clinical Project Manager (CPM)
联系方式
蔡伦路780号701室
公司信息
爱科百发生物医药(www.arkbiosciences.com)是一家专注于抗病毒创新药研究及开发的生物技术公司，致力于成为全球性的抗病毒创新药及儿科药研发生物技术公司，成立3年多以来已成立核心研发和管理团队，运营良好。公司总部坐落于中国药谷上海张江高科技园区，此外还在中国苏州、澳大利亚设立分公司。公司目前主要研发产品抗呼吸道合胞病毒（RSV）的新型药物已经进入临床II期试验阶段，并有望成为全球第一个专门用于抗RSV病毒感染的临床药品，另有3个应用于流感病毒和乙肝治疗的产品处于研发阶段。 Ark Biosciences is a biotech startup company focusing on innovative drug discovery and development, especially in the respiratory virus field, for world-wide markets. It is headquartered in the Zhangjiang Hi-tech Park of Shanghai, the heart of pharmaceutical innovation in China. Ark Biosciences has its own active discovery programs, those of partners, and licensing in drug assets for clinical development in the Asia-Pacific region. Ark Biosciences intends to become the driving force behind China's evolution into a global innovation center for drug discovery and development.
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