Clinical Operation Director (职位编号：20130816003) 上海

月薪： 1.5-3万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招2人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 定期体检
  • 专业培训

职位描述

职位描述： Division/Dept:Clinical OperationReporting to:Managing DirectorJob Level:No. of direct reports, if any:Position Description:The Director of Clinical Operations will provide operational and implementation oversight for clinical studies under the guidance of the Head of New Drug Development Service Business Group (NDDSG). The Director of Clinical Operations will manage all aspects of clinical operations for assigned clinical trials to assure the highest standards of clinical trial execution and GCP. The Director will manage an internal clinical operations staff and also interface with contract research organizations (CROs), when there is a need, and clinical sites involved in the clinical trials. The Director will also collaborate with other functional divisions, such as Project Management; Clinical Sciences; and Biometrics. The Director of Clinical Operations will serve as mentor and direct supervisor to clinical operations staff.Responsibilities:1.Direct planning, execution and reporting of multiple clinical programs.2.Direct study management personnel to ensure timely delivery project deliverables and assure adherence to GCP standards and SOPs.3.Manage FTE resource requirements and participate in headcount planning. Lead the performance review process for direct reports. Identify and address performance issues and training needs. Serve as a resource and mentor. Support recruitment of staff by reviewing resumes, and evaluating candidates. Make hiring recommendations. Review and approve travel and expense reports for team members.4.Interact with other functional areas as well as cross-functional teams to ensure timely delivery of project deliverables with consistent high performance and quality of work. Work with other functional personnel as required to appropriately resource project teams.5.Develop and assess metrics to support study and project targets and deliverables.6.Assess and evaluate processes and support implementation of appropriate plans for action. Identify new process opportunities, drive and support process improvement initiatives and work with appropriate personnel to implement and re-evaluate processes. Identify and recommend solutions to problems and/or issues with personnel and/or processes across departments.7.Lead vendor selection and review process. Direct vendor and site contracting and mange change order processes.8.Direct management of the study budgets and specifications to ensure project/study goals are achieved within scope. Work with management to assure study priorities are satisfied and budgets are met. Ensure that tracking, financial and resourcing tools are effectively utilized. Support identification and issue resolution of budget and resourcing issues.Qualifications:Education and Experience:1.Advanced degree (MS/PhD/PharmD/MD) with sciences major preferred, but will consider direct relevant experience plus BA/BS in lieu of advanced degree.2.Experience: 10 or more years R&D clinical operations experience in biotech, pharmaceutical or clinical CRO experience. Phase 1-3 experience required.Skills/Competencies:1.Extensive knowledge of cGCP, ICH, FDA and EMEA regulatory requirements. Strong project management, analytical and problem solving skills. Ability to manage, motivate and develop people. Travel as needed to resolve field issues and meet with sponsors.2.Excellent verbal and written communication skills.3.Good verbal and written English or other second language skills.4.Strong computer literacy e.g. MS word, Excel, PowerPoint, internet.5.Excellent organizational, record retention and time management skills.公司网站：http://www.apluscro.com/ 职能类别： 医药技术研发管理人员 临床协调员 关键字： 临床监查 试验管理 带薪年假 周末双休 话补 出差补贴 年终双薪

联系方式

上海市长宁区仙霞路317号2516室

公司信息

佳永医药咨询（上海）有限公司，是台湾佳生集团(PPC Group)旗下, 专责新药研发及临床试验的佳正国际股份有限公司(A+ Inc.) 在中国的分公司，台湾佳生集团成立于1997，是一家服务于亚太区制药企业，生物技术公司以及医疗器械公司的合同研究组织（CRO），主要提供新药研发的I – IV 期的临床试验服务。目前有员工580多人，主要分布在台北，首尔，东京和上海。 PPC集团网站 http://www.ppccro.com 佳永医药咨询（上海）有限公司网站：http://www.apluscro.com 公司地址：上海市长宁区仙霞路317号(远东国际广场B栋) 2516室

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