- 3-4年经验
- 本科
- 招2人
- 02-04 发布
职位描述
Position Description: The project manager (PM) is responsible for overall management of projects conducted in China to ensure the adherence of the project to quality standards and the approved timeline and budget in the service agreements. PM leads the project team and the internal/external communications, and identifies suitable resources to facilitate efficiency improvement for project execution. Responsibilities: 1. Be responsible for the overall project planning and execution of project timeline, budget, scope, and quality regarding the assigned projects. 2. Lead project team to develop project specific management plans, tools and templates. 3. Control and monitor the project execution with the risk management plan 4. Be responsible for the trial documents filing and all operations complying with ICH, local regulation, SOPs and project plans. 5. To follow the company SOP or project-specific QC processe for the tasks coordination to solve the emerging issue/problem as necessary. 6. Work with the line manager of the project team member to facilitate issue resolution and resource management. 7. Participate in the internal and external communication for issue identification/resolution and customer satisfaction. 8. Be responsible for participating and contributing to the BD project bidding and marketing activities, and to facilitate the success of business explore and contract award. Qualifications: ? A Bachelor of Science (or medical related field) degree. Advanced degree in science or medical related field is preferred. ? At least 3 years’ experience in clinical operation. ? At least 2 years’ experience in project management with successful performance records. Project Management Professional (PMP), or equivalent certification is preferred. ? Familiar with activity processes throughout a clinical trial with good knowledge in ICH-GCP and local regulations. CCRA of ACRP Certification is preferred. ? Excellent customer management and problem resolving skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall program. ? To be proactive, flexible, organized, and aim to mitigate risk, understanding plans and outcomes fluctuate, and be highly communicative during the entire process. ? Good in maintaining good working relationships with sponsors and project team members. ? Fluent communication of speaking and writing in English. Japanese communication capability is PPC China. 职能类别: 临床研究员 生物工程/生物制药 关键字: 项目经理 PM Project Manager
联系方式
黄陂南路838弄
公司信息
PPC佳生(Protech PharmaservicesCorporation)成立于1997年,致力于为国内外制药企业及生物技术公司提供专业化临床研究服务,为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今,自成立以来,PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目(包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD);并且还执行了超过400个新药后期临床试验项目;所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地,生物样品实验室开发约300种药品分析方法,以丰富的执行经验提供海内外客户优质服务。2012年,PPC佳生于台北(McKay memorial Hospital)建立了第一家下属I期临床试验中心,并于2016年作为主要投资方与徐州医科大学资源共享,优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。
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