Clinical Trial&Medical Manager 上海

月薪： 1.5-2.5万/月

该公司所有职位
  • 5-7年经验
  • 硕士
  • 招1人
  • 03-06 发布
  • 周末双休
  • 带薪年假
  • 五险一金
  • 节日福利
  • 餐饮补贴
  • 补充医疗保险
  • 补充公积金
  • 年终奖金
  • 十三薪
  • 通讯补贴

职位描述

Clinical Trial&Medical ManagerJob Descriptions: Take responsibility for clinical trials (phases I to IV) and budget implementation plan according to company programs plan, in respect of: CROs selection, planning, budget set-up and follow-up, implementation, conduct, reporting activities; Communicating with Principal investigator and CRO for drafted the clinical trial protocol in conjunction with Medical department of Ethypharm HQ; Ensure that the clinical trial compliance with the GCP, ICH, protocol and SOP, timelines and budget; Cooperating with other department to the product marked development; Job Responsibilities: - Responsible for preparing detailed timelines and establishing clinical trials’ milestones for assigned projects, ensuring they are performed to the most rigorous standards of quality, timely delivery and within budget - Foster and develop a team approach to all activities (external, internal) associated with the implementation and follow-up of clinical trials- Responsible for CRO selection and completing the CRO selection report; drafting the technology service contract and other affairs that coordinate with CRO.- Responsible for discussing with CRO about the clinical protocol for drug registering and Post marketing study. - Responsible for maintain a level of medical- scientific expert resource, and consulting the experts for clinical protocol writing in conjunction with Medical department of Ethypharm HQ;- Establish and maintain excellent professional relationships between the company and external experts- Identify (in conjunction with the selected CRO) high quality investigational centers to conduct the trials- Conduct site visit as required- Prepare and/or manage with the CRO the production of all the documents necessary to implement and monitor the trials (eg, case report form, information letter, informed consent, …)- Ensure that all the mandatory approvals are obtained to allow the conduct of clinical trials- Responsible for regular advancement reports- Responsible for checking and accepting the clinical study report to ensure it compliance with GCP and other relevant requirements in conjunction with Medical department of Ethypharm HQ;- Responsible for collecting and reviewing the medical literature for the relevant products during the study;SKILLS AND ABILITIES- Master's degree, major in clinical medicine, clinical pharmacy and other related majors;- At least 5 years clinical project management experiences - Experience of preparing clinical study documentation- Experience of CRO management, team management (external, internal)- Experience of managing clinical trials’ budgets- Familiar with GCP and ICH- Good knowledge of national legal rules, could carry o ut independent management of clinical projects;- Successful experience in clinical program management, and keep a good relationship with clinical experts;- Fluent and professional English in writing and speaking; - Excellent communication, negotiation, networking and interpersonal skills; Proven track record in contract negotiation and problem resolution ability. 职能类别： 生物工程/生物制药

联系方式

上海市南京西路388号仙乐斯广场1805-1806室

公司信息

爱的发制药集团是以研发为主导的国际化药物释放技术公司，公司拥有一系列的药物释放技术平台，可以满足从传统小分子到生物大分子递送的各种要求，基于其全球的5个研发中心和4个生产基地，62组全球性的专利保护，爱的发为客户提供从研发、注册到生产的全方位服务。 目前，公司已经拥有超过1600项的市场授权，为50多个化合物开发了不同的配方，爱的发将产品授权客户，在70多个国家上市，包括诸多知名跨国公司在内的超过200家制药企业选择爱的发作为他们信赖和合作伙伴。 作为第一批中法合作的制药企业，上海爱的发成立于1995年11月，基于其创新的药物释放技术，上海爱的发在中国开发和上市了一系列产品，并为客户提供包括可行性研究、工艺放大、临床实验、注册和工业化生产的全方位服务；作为中国药物释放产业的领军企业，上海爱的发通过提高现有产品的治疗效能和竞争力，帮助合作伙伴延长产品的生命周期和专利保护，而所做的提高和改进都达到或者超过生产规范国际标准的要求。

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