- 8-9年经验
- 本科
- 招若干人
- 11-09 发布
职位描述
职位描述: Primary Function:This position is responsible for managing and delivering the operational and financial aspects of one or more clinical studies.Key responsibility:Oversee interdisciplinary clinical research programs.Represent CCBR to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.Lead clinical team to ensure quality, timelines and budget management.Responsible for TMF Management Plan and quality and completeness of TMF for assigned projects.Accountable for the financial performance of each project assigned.Coordinate activities and deliverables of all study conduct partners and proactively indentify and manage issues.Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.Responsible for study management components of inspection readiness for all aspects of the study conduct.Oversight for development and implementation of project plans.Plan, coordinate and present at internal and external meetings.Prepare project management reports for clients and management.Implement resource strategies to achieve project goals.Developing contingency planning and risk mitigation strategic to ensure successful delivery of study goals.Participate in bid defense meetings where presented as potential project manager/director.May train and support new project managers.Identify and implement performance improvement and operational efficiencies within the project delivery organization.Qualification:Bachelor’s degrees required; MS, MPH, PharmaD, PhD, or other advanced life science degree preferred.Ideally project management qualified PMP/ equivalent.10 yrs relevant clinical research experience with an understanding of clinical drug development and clinical trials operations.6 yrs experience managing projects.Strong knowledge of GCP/ICH guidelines and other applicable regulatory requirements.Strong organizational skills.Strong ability to manage time and work independently.? Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade.High level of competence in English language.Ability to travel as necessary (approximately 25%)Excellent written and oral communication skill 职能类别: 医药技术研发管理人员
联系方式
昌平区生命园29号中关村生命科学园创新大厦C座一层
公司信息
CCBR,临床与基础研究集团公司(Clinical and Basic Research Group)由全球骨质疏松领域的开拓者与领航者Dr.Claus Christiansen于1992年创办。总部位于丹麦,是一家专门从事临床药物研究的集团公司。在全球17个国家有40多家研究型医院(即临床研究中心),并且我们提供全球一流的医学影像学分折技术及心血管安全指标分析。 西斯比亚(北京)医药技术研究有限责任公司是CCBR在中国区的子公司,创办于2005年9月。作为全球领先的SMO集团,CCBR是国内仅有的全外资SMO。在中国的业务主要包括与国内各大医院按GCP原则联合开展临床研究以及外派临床研究协调员(CRC)业务。目前我们在全国50多个城市200多家医院有CRC业务。
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