职位目的：

负责医学总部临床研究质量控制管理，与其他职能部门的顺畅高效合作，以确保公司发起及研究者发起的项目的成果达成（包括全球性研究，ASCA/亚太区研究和中国当地研究）。

Responsible for the clinical study quality control management of Medical Division, cooperate with cross functional smoothly and effectively，make sure the delivery of the  studies initiated by the company and sponsor-investigators (including global study, ASCA/Asia Pacific study and local study in China).

具体职责：

1.负责临床研究质量控制：通过质量管理计划，有计划地实施、维护和提升临床研究质量；以及培训工作； Responsible for clinical study quality control: implementing, maintaining, and improving clinical study quality in a planned manner through quality management plan; And training in medical division;

2.通过实施培训和QC等过程的质量监督和质量控制管理，控制临床研究按照相关质量管理体系的要求及SOP开展医学总部临床研究；By implementing supervision and quality control management through training and QC processes, control clinical study to be conducted in accordance with the requirements of the relevant quality management system and SOP.

3.负责组织临床研究流程手册文件起草、修订及审核，获得直属上级/医学总部总经理等审批，监督以确各部门的职责得到有效履行；Responsible for organizing the drafting, revision, and review of clinical study process manual documents, obtaining approval from superiors/medical division general managers, etc., and supervising to ensure that the responsibilities of each department are effectively fulfilled.

4.按规定对临床研究必备文件（TMF-trial master file）以及临床研究管理系统（iENVISION System）进行监督管理，审核存档临床研究文件，以确保符合相关法律法规以及SOP的要求；Supervise and manage the necessary clinical study documents (TMF trial master files) and clinical study management system (iENVISION System) in accordance with regulations, review and archive clinical study documents to ensure compliance with relevant regulations, and SOP requirements.

5.负责偏差、变更、CAPA的管理，确保所有与质量有关的豁免经过审核和批准，确保所有重大偏差经过调查并得到及时处理；Responsible for managing deviations, changes, and CAPAs, ensuring that all quality related exemptions are reviewed and approved, and ensuring that all major deviations are investigated and promptly addressed.

6.负责与RDPV QA以及内审科的沟通，评估落实相关的要求，例如协调完成供应商资质评估、内审计划实施的整体协调配合，以及提出医学总部临床研究QA支持需求等。Responsible for communicating with RDPV QA and internal audit, evaluating and implementing requirements, such as coordinating the completion of supplier qualification evaluations, and proposing clinical study internal audit and support needs from the medical divisions to RDPV QA.

7.与其他职能部门的顺畅高效合作，统筹研究团队各职能部门解决研究中的问题，定期向相关利益方报告研究进展。Cooperate with cross functional smoothly and effectively, coordinate the functional team members of the study team to solve the problems in study, and regularly report the study progress to t stakeholders.

8.完成直线经理指定的其他工作。Complete other tasks assigned by the line manager.

岗位要求：

1.本科（Prefer硕士）及以上, 医学、药学、生命科学或者相关领域优先 Bachelor's degree (Prefer Master) or above, medicine, pharmacy, life science or related fields are preferred

2.6年以上医药行业工作经验，3年以上大型MNC或跨国CRO质量管理或临床研究项目管理经验 More than 6 years of experience in the pharmaceutical industry, more than 3 years of experience in quality control management or study management of big MNC or multinational CRO clinical studies

3.中英文熟练 Proficient in Chinese and English

4.熟练掌握监查技能，包括研究开始、进行和研究结束的经验。Master the monitoring skills, including the start-up, enrolment and close.

具备质量管理或临床试验项目管理经验，优先考虑IV期临床试验、IIS和真实世界研究经验。3. Have experience in quality control management or clinical study project management, prefer phase IV clinical trial experience, e.g., Phase IV、IIS and RWS.

掌握GCP/ICH指南、HGRAC和其他适用的监管要求。Master GCP/ICH guidelines, HGRAC and other applicable regulatory requirements.

了解临床试验整体流程、跨部门协作，包括数据管理、医学监查、医学写作、生物统计学流程。Understand the overall process of clinical study and cross function collaboration, including data management, medical monitor, medical writing, and biostatistics process.

较强的沟通和人际交往能力，较强的组织协调和解决问题的能力。Strong communication and interpersonal skills, and strong ability to organize, coordinate and solve problems.

具备多任务多职责管理能力。Have the ability to manage multiple tasks and responsibilities.

5.熟练掌握MS 办公软件（如Word, Excel, PowerPoint, Outlook）Proficient in MS office software (such as Word, Excel, PowerPoint, Outlook)