Medical Monitor
PPC佳生
- 公司规模:500-1000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:2020-09-21
- 工作地点:上海
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:2.5-3万/月
- 职位类别:其他
职位描述
- Provide medical/scientific guidance on current, pending and future proposed projects
- Provide medical consulting service regarding phase I – IV clinical research studies.
- Serve as a resource to identify experts to serve as consultants to Company or Sponsors or for various Sponsor committees (e.g., Steering Committee, Data Safety Monitoring Committee, Adjudication Committee, etc.).
- Advise, support and assist in the production of stage 1 – 3 feasibility studies.
- Function as a medical monitor (during business and/or non-business hours) for various clinical studies reviewing study related materials as per contract (protocol, investigator’s drug brochure, informed consent form template, case report forms, etc.) and interacting (with appropriate documentation of the contact) with sites, internal and external team members in an effort to help maintain patient safety and the medical/scientific integrity of the study.
- Provide project specific/therapeutic training.
- Conduct a medical review of patients’ safety and laboratory data.
- Review and identify queries pertaining to individual Serious Adverse Events to assist the Sponsor in establishing an accurate safety profile for their IP/IMP.
- Review SAE descriptive narratives written by Company Safety Officers.
- Assess and complete expectedness and causality for SAEs.
- Assist in the preparation of clinical development plans in collaboration with others.
- Liaise with expert opinion leaders and to organize expert opinion leader meetings when requested by internal or external clients.
- Support business development activities (provide input into proposals, bids, protocols/synopses; attend/ present at client proposal meetings, etc.)
- Comply with Company Standard Operating Procedures, Worldwide Practice Guidelines, Regulatory Authority requirements relating to Good Clinical Practices and legal/confidentiality matters relating to the conduct of clinical research.
- Maintain one’s medical credentials and to keep up to date with medical/scientific information and the practice of Pharmaceutical Medicine.
- Travel domestically and internationally as required to carry out the job responsibilities as noted in this section
- Perform other reasonable activities as instructed by his/her direct line manager(s) (Sr. Medical Director and/or Chief Medical Officer).
职能类别:其他
公司介绍
自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今,PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目,其中涉及24个主要研究领域。
另外,PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
2012年,PPC佳生在台北(MacKay Memorial Hospital)建立了***家专属I期临床研究中心;2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心;2018年,PPC佳生又分别与徐州市中心医院,湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前,PPC佳生已有5家自主运营的I期临床中心。
联系方式
- Email:mavis.yao@ppccro.com
- 公司地址:地址:span朝阳门外大街18号(丰联广场)