北京招聘

工作职责:

Duties and Responsibilities:

? Responsible and accountable for one or more clinical trial(s).

? Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).

? Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.

? Responsible for effective communication within the Clinical Project Team and with functional management.

? Provides regularly updates regarding the status and progress of the trials (Therapeutic Lead, Business Alliance, etc.)

? Manages the project(s) within the approved budgets and timelines.

? Responsible for writing of clinical project deliverables such as protocol, final study report, study manuals, study tools, operational plans, etc. within the CPP framework.

? Prepares investigational site lists and participates in reviewing and approving investigational sites.

? Directs forecasting of devices necessary for project in collaboration with supply-chain; reviews and approves various support system specifications (e.g. IVRS, etc.).

? Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team.

? Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.

? Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.

? Prepares and presents the status of the clinical project(s) to the Clinical Management Board.

? Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.

? Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable MicroPort SOPs and policies.

? Represent the company at Investigator/ Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings.

? Participate in external and internal audits/inspections, as required

任职资格:

Competency Expectations:

Ability to understand strategic goals and match the business needs of the company. Ability to develop good interpersonal relationships with medical professionals. Good verbal and written communication and presentation skills. Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies. Ability to independently manage and provide significant tactical and leadership guidance to clinical team. Independently motivated. Demonstrated ability to manage multiple projects, complex projects and international projects.

Working Conditions:

General office environment, approximately 10-30% travel to research laboratory or hospital settings, meetings and other MicroPort facilities. Potential exposure to blood borne pathogens and other potentially infectious materials

微创？起源于1998年成立的上海微创医疗器械（集团）有限公司，总部位于中国上海张江科学城，产品已进入全球逾万家医院，是一家领先的创新型高端医疗器械集团，现有员工近6,000名，平均每8秒就有一个微创的产品被使用。
微创？致力于提供能延长和重塑生命的普惠化真善美方案。在中国上海、苏州、嘉兴、东莞，美国孟菲斯，法国克拉马尔，意大利萨鲁贾和多米尼加共和国等地均建有主要生产（研发）基地，形成了全球化的研发、生产、营销和服务网络。微创？已上市产品约300个，覆盖心血管及结构性***病，电生理及心律管理，骨科与软组织修复，大动脉及外周血管疾病，脑血管与神经科学，内分泌管理等生命科技，外科及医疗机器人，泌尿、妇科、呼吸、消化，医美及康复医疗，与体外诊断与影像等十大业务集群。
微创？专注于自主创新并一以贯之高强度投资于研发，现已拥有专利（申请）3,500余项（国外2,000项），先后5次获得中国国家科学技术进步奖（其中一项为企业创新平台模式奖）和多个省部级科技进步奖，16个产品进入中国创新医疗器械注册绿色通道（截至2019年6月）。微创？尊崇循证医学，几乎所有核心产品与解决方案的临床应用效果（经验）都在全球主流学术杂志上得到了发表。