长沙招聘

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.

PPC佳生集团（PPC Group）是一家成立于1997年的临床CRO公司。总部设立于上海，并分别在台北，徐州，北京，南京，首尔及东京设立了分部及分公司。
     自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今，PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目，其中涉及24个主要研究领域。
     另外，PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
     2012年，PPC佳生在台北（MacKay Memorial Hospital）建立了***家专属I期临床研究中心；2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前，PPC佳生已有5家自主运营的I期临床中心。