长沙招聘

Reporting to:

Group QA Head, or Group CEO

Position description:

Leading, planning and organizing of division operations to provide clinical trial services required for customers, and achieving division goals.

Responsibilities:

• Manage staff in accordance with organization’s policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.
• Direct the hiring and selection process for new staff by conducting candidate review through participation in the interviewing process. Establish methods to develop and evaluate onboarding processes.

• Develop standard processes to ensure that staff has the proper materials, systems access and training to complete job responsibilities. Oversee the execution of the training plan, SOP review and mentored training experiences.

？   Lead or Support customer audit and regulatory inspections.

？   Handle other temporary assigned tasks by upper management.

？   Ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with Principles of GLP and regulatory requirements.

？   Ensure the maintenance of an historical file of all Standard Operating Procedures.

• Perform the tasks assigned by line manager.

Qualifications:

Education and Experience:

？   Five years of clinical related experience or three years of management experience.

Skills and Competencies:

？   Good management, planning, organization and leadership skills.

？   Good knowledge of regulatory requirements.

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。