南京招聘

  

Background

  

Protech Pharmaservices Corporation (PPC) was founded in 1997 to meet the growing demands for R&D outsourcing from the Pharmaceutical and Biotech industries in the Asia- Pacific region. PPC is the largest CRO in Taiwan to offer a complete range of Clinical Research and Contract Laboratories services. In order to build up an international CRO network, PPC has formal alliances in Japan. In addition, PPC has branch operations in China (Beijing, Shanghai), Japan, and Korea.

  

Responsibilities

  

• Development and documentation of programs used in the production of computer generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data

• Communicate with statistician and medical manager to fully understand analysis requirements for assigned clinical projects

• Perform all SAS programming tasks with high quality in the agreed timeline, and work closely with data management to assure data quality

• Participate in review of protocol, statistical analysis plan (SAP), data management plan (DMP) and case report form (CRF)

• Preparation of electronic submission of clinical data

          

  

Education/Qualifications

  

• BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation

• In-depth knowledge of Base SAS, SAS/STAT, SAS Graph, SAS SQL and SAS Macro Language. SAS Certification is preferred, not required

• Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH-GCP etc.)

• Effective communication skills and ability to establish and maintain effective working relationships with study team members

• Ability to work under pressure and manage multiple projects simultaneously

• Solid analytical and problem solving skills paired with strong attention to detail

• Experience in CDISC, aCRF and XML is preferred

              

  

Experience

  

2-6 years of related experience

  

  

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。