上海招聘

1. 隶属部门/Situation in structure

    属高级医学经理直接领导

    Directly lead by Senior Medical Manager      

2. 职责/Mission    

负责临床试验运营方面的计划和管理，包括CRO和供应商的管理和监督，以确保项目里程碑和目标的实现

Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met

3. 主要工作/Main Activities

• 在指定的治疗领域和/或疾病领域掌握一定程度的医学科学知识,包括与相关产品有关的医疗和临床范畴
• 组织和管理临床试验,以进行注册和市场推广
• 负责临床试验的项目计划和预算管理
• 确保临床试验符合政策、方案、时间表和SOP
• 组织并管理临床试验。监控整个临床试验过程,熟悉从I期到IV期的临床试验
• 负责机构的选择、协议的起草和临床试验协议的谈判
• 管理第三方供应商
• 负责项目实施过程中的各种协调工作。与研究人员保持良好的沟通与协调
• 根据项目的测试要求，正确地建立和管理文件
• 提供注册药物的临床试验文件
• 负责核查所有推广材料
• 其他上级安排的工作
• Maintains a level of medical-scientific knowledge in an assigned therapeutic area and/or disease state(s) involving medical and clinical issues related to relevant products
• Organize and manage the clinical trial for the purpose of registration and marketing promotion
• Responsible for the project plan and budget for clinical trial
• Ensure that clinical trial compliance with the policies, protocol, schedule and SOP
• Organize and manage the clinical trial. Monitor the entire clinical trial process, familiar with the clinical trials from Phase I to Phase IV
• Responsible for choosing the institution, draft the agreement and negotiate for clinical trial
• CRO management and oversight
• Responsible for the project all kind of coordination work in the implementation process. Keep and Maintain good communication and coordination with researchers
• According to the testing requirements for the project to properly establish and manage the documentation
• Provide the clinical trial document for the drug registered
• Responsible to check all promotion materials

• Other assignment from superior                                                                                                   

4. 自主性/Automaticity

• 积极参与，与研发团队，业务拓展，市场和项目部门的沟通和协作
• 有创意、团队合作融洽、解决问题好和能适应在压力下工作
• 与客户和潜在客户建立持久的关系
• 与业务部门的同事、高级和初级同事保持良好的工作关系
• 与客户建立并保持良好的工作关系
• Active participation, communication and collaboration with R&D team, BD, Marketing and Project department
• Creative, Team player, problem settled and work under pressure
• Build lasting relationships with clients and prospects
• Maintain good working relationships with colleagues, senior and junior colleagues across the business unit
• Establish and maintain effective working relationships with clients                                              

5. 能力要求/Competence

• 医学或药学专业硕士学位
• 3年以上跨国制药公司相关工作经验，有医院医生经验者优先
• 流利及专业的英文及普通话(写作及口语)
• 制药业现有的网络和关系
• 了解中国药品市场、法规和法规
• 临床研究经验、项目管理经验和临床操作经验；或同等学历、培训经验、深入了解和运用技巧
• 熟悉适用的临床研究法规要求，如临床试验质量管理办法(GCP)，ICH-GCP
• 熟悉医疗和方案知识
• 有能力制定预算和控制成本
• 较强的组织和解决问题的能力
• 有能力按照适当的质量和时间标准交付结果
• 良好的团队领导能力，良好的判断力和有效的表达技巧
• 办公软件和计算机技能，包括微软办公应用程序
• Master's degree major in medical science or pharmacy
• At least 3 years relevant experience with multinational pharmaceutical company, Experience as a doctor in hospital is preferred
• Fluent and professional English and Mandarin (writing and speaking)
• Existing network and relationship in pharmaceutical industry
• Knowledge of China pharmaceuticals market, rules and regulations on drug development
• Clinical research experience, project management experience and experience in clinical operations; or equivalent combination of education, training and experience in depth knowledge of, and skill in applying
• Familiar with applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Depth therapeutic and protocol knowledge
• Ability to set up the budget and control costs
• Strong organizational and problem solving skills
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics
• Good team leadership skills, good judgment and effective presentation skills
• Software and computer skills, including MS Office applications

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***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。