研究中心管理团队负责人Site Management Lead招聘_缔脉生物医药科技（上海）有限公司最新招聘信息-猎才医药网

职位描述

Position SummaryLead and manage the team of site management ensuring timely and cost effectively conduct of various types of clinical trials, with high quality and in accordance with ICH GCP, local regulatory requirements and the SOPs of dMed and/ or Sponsor.Responsible for the implementation of all contracted and assigned clinical trials. Make sure the effective plan and management of site in clinical trials, including monitoring and all the other trial management related activities in whole clinical trial execution process from site selection, trial preparation, initiation and conduction, study report inputs, assisting on site study summary approval, study report inputs, and up to site close-out.It will be achieved through building, maintaining and developing a team of site management with appropriately qualified and trained staff, such as Clinical Research Associate and Site Management member at different levels, through effective communications, and developing and maintaining strong working relationships with relevant functional lines in dMed and sponsor representatives, as well as site people. Able to display dMed values in how the team delivers against goals, and demonstrates an entrepreneurial style in leading her clinical research functions.The degree of responsibilities accorded to an Associate Director, Director or Sr. Director will reflect their level of experience and contribution that they can make to the projects and clinical operations.Key Responsibilities- Clinical Trial Operations - Manage the conduct of Phase I, II, III and IV clinical research programs at the site level, to make every effort in reaching the set project timeframe- Proactively anticipate and resolve issues, and share best practice in site management cross sites or projects- Ensure the conduct of clinical trials in accordance with ICH-GCP, local Regulatory requirements and applicable standards of dMed and/or sponsor- Be familiar with protocols, CRFs and other scientific or operational documents and provide appropriate feedback to owners, issue approvals as applicable- Support the team for preparation, submission, and prosecution of IRB/IEC approvals, HGRAC approval to initiate clinical trials, including recruitment plan, study monitoring plan and investigators’ meeting- Support and lead the team to complete the feasibilities at protocol or site level, and provide appropriate feedbacks- Deliver against agreed commitments to sponsor in terms of quality, quantity, timeliness and cost in the execution of clinical research in the country- Partner with sponsor and related functional lines internal, in the development, adoption, and implementation of processes and systems necessary for the effective conduct of clinical trials, including site selection- Responsible for the administration of clinical trials including cost control per study budget, documentation, vendor management, provision of supplies to investigators and monitoring of trial progress- Clinical Research Team Management- Responsible for the recruitment and development of site management staff to ensure the appropriate levels of skills to achieve clinical research objectives. Build up team with high competency.- Responsible for identifying training needs for clinical research staff, supporting trainings and checking training records, providing close coaching to her staff to maintain a highly effective clinical research team- Responsible for ensuring the performance management of clinical research staff including goal setting, performance reviews, career guidance and developmental opportunities- Responsible for budget planning and management for both operational cost of clinical research team and project cost- Demonstrate a strong leadership in leading clinical research team to achieve clinical research objectives and department objectives- Actively create an environment of openness, innovation and inclusiveness that promote effective changeEducation and Key Competency RequirementsProfessional Experience & Education Requirement- Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); Advanced Degree in biomedical sciences (MSc, PhD, MBA) preferred- Minimum 12 years of experience in clinical trials as CRA, Site Management (or equivalent), including no less than 3 years project management and people management experience, and present excellent performance and good potential to engage subordinates to achieve the team goal- Good working knowledge of GCP guidelines and good sense to regulatory requirements- Proficiency in Basic Microsoft Word, Excel, ppt and familiarity with use of database- Knowledge of drug development process; Established good relationship with site and investigatorsKey Competency Requirement- Functional ability- Strategic awareness- Organizational commitment and result Oriented- Strong Leadership skills- Ability to identify and lead change; And Sound decision making capabilities- Well-developed of communication (Chinese & English), presentation, and interpersonal skills- Teamwork and collaborative working attitude- Demonstrate thought leadership and continuous improvement contributing to project outcome- Facilitation and influence skills with multiple parties involved- Demonstrated capability to plan and prioritize competing objectives; Strong project management and problem solving skills- T Result and quality driven- Customer orientation and focus on company- Excellent people leadership and team management skills, particularly may work in remote environment- Able to create engaged and inclusive environment- Drive changes and continuous enhancement in process, quality, efficiency and capabilities ？Important Note: 'Salary range' in the job requirement is just for reference. The salary will be defined after full evaluation of the candidates through test and interview. 备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。职能类别：医药技术研发管理人员关键字：研究中心管理负责人 Site Management Lead

公司信息

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。我们是谁？基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。为什么选择我们？ · 缔脉定位于以高品质服务和专业精神成为业界典范。· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。创始人及部分核心专业领域创始人 - 谭凌实博士: 拥有20多年跨国一流制药公司总部高级管理经验. 此前担任辉瑞公司全球药物开发运营副总裁, 在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点,成为辉瑞全球核心的研发中心之一, 承担药物临床开发,安全风险管理, 注册,临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作,比如复旦大学, 北京大学，交通大学. 培养了不少拥有专业技能和行业知识的临床数据管理和编程人才.谭博士有在美国建立初创企业的经验, 且在美国一流制药企业研发中心工作多年. 谭博士拥有生物统计博士学位。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2018-01-25

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