Sr Clinical Study Management Specialist

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The PositionJob Summary职位概述: Develop product related clinical study based on overall medical strategies and implementation. 基于整体医学策略和方针，开发产品相关的临床研究。 Main Tasks & Responsibilities 主要工作职责 : 1. As a project leader to lead the whole study activities, including but not limited to site selection, Ethics committee review, study agreement signing, investigator meeting, enrollment, trial master file management, site monitoring, source data verification and site close-out. 作为项目负责人，负责临床研究的整体实施与管理，包括但不限于研究中心选择，伦理审批，研究协议签署，研究者会的召开，入组，研究文档管理，研究中心监查，原始数据核查，研究中心关闭等。 2. As a project leader to manage and track the study timeline, study budget and products of company sponsored studies. 作为项目负责人，管理并跟踪公司发起研究的时间进度，研究预算和研究产品。 3. Ensure the clinical studies are in compliance with local regulations, ICH GCP and Roche SOPs. 确保所有研究符合当地法律法规的要求，ICH GCP以及罗氏SOP。 4. Manage the review and approval processes of investigator initiated studies and track the study progress. 对研究者发起的研究进行审核和批准流程的管理，并追踪研究进展。 5. Work with global MSA and clinical operation team to have cooperation on global multicenter studies. 与罗氏总部MSA及临床研究团队合作进行国际多中心研究。 6. Establish and maintain the good relationship with KOLs, investigators and sites. 与KOLs以及临床研究的研究者保持良好的沟通。 7. Assist line manager in other clinical study related tasks or other routine tasks. 协助直线经理进行其他的研究相关工作以及其他日常工作。 8. Other projects or tasks assigned by line manager 主管指派的其他任务 9. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection 遵循罗氏所有合规要求，包括但不限于罗氏信息安全，罗氏商业中的行为，罗氏竞争法互动对话，罗氏安全健康环境等，合法合理开展业务活动 Basic Requirements of the Job基本任职资格: Education& Qualifications教育背景与专业资格: Master / Bachelor Degree in Clinical Medicine or Clinical laboratory education related background. 临床医学或者临床实验室教育等相关背景硕士/本科学历 Experience工作经验: 3 +years of diverse healthcare experience in medical or clinical research in pharmaceutical, medical device or IVD companies. 3年以上在制药，医疗器械或IVD行业有医学或临床研究丰富的医药经验 Professional Capabilities/Skills专业能力/技能: 1. Marketing Expertise 市场营销专业知识 2. Planning & Organizing 计划和组织 3. Internal Cooperation 内部合作 4. Medical-related Product & Applications Expertise 医药相关的产品和应用专业知识 5. KOL Orientation & Relationship Management KOL方向和关系管理 Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.