天津招聘

Accountability：

一、Accountability

· Responsible to manage clinical study support activities according to SOP and GCP/ICH guidelines and other regulatory requirements.

• Support clinical study on documentation, system, finance and study teams’ other administrative support.

二、Clinical Projects Support Accountability

• Study drug supply management and other supply management to ensure study supply delivery met study requirement.

• Study operation support including but not limited to EC submission, HGRAC submission, contract signing and payment processing.

• Study documentation and TMF management. Study document and presentation material formatting and quality check.

· Vendor management activities including but not limited to contract sign-off, vendor access process, and vendor payment.

· System management and support including but not limited to initiate and lead the set-up of electronic Trial Master File (eTMF); work with project manager on Trifecta set-up, user access management and oversight of site compliance.

· In-house support to all kinds of audit or inspection.

· Maintain a central database for study, site, investigator, and contact information

· Other clinical development supports.

• Work on non-project work in process improvements.

  
  

  
  

三、Administrative Support Accountability

· Contract sign-off and stamping

· Contribute to the preparation of internal and external meetings. Including but not limited to meeting logistics, vendor management, slide deck preparation, meeting minutes preparation, on-site support, etc.

· Stationery and other office supplies ordering

• Ad-hoc tasks per needs.

Qualifications：

一、Education

1. Bachelor Degree is required.

二、Skills

1. Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.

1. Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management.
2. Good technical/IT skills.
3. Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

1. Fluent in English. Travel as required.

三、Experience

1. Minimum of 2 years working experience in the pharmaceutical industry or healthcare discipline

安斯泰来集团介绍：

安斯泰来制药集团是一家总部位于日本东京的研发型制药企业，在全球范围内研发、生产、销售创新型医药产品。我们的使命是不断提升企业价值，致力于通过创新可靠的医药产品为全世界人民的健康做贡献实现我们的存在意义。
安斯泰来制药集团已经在器官移植领域和泌尿领域成为全球专业治疗领域领导者（GCL）。我们结合自身的研发实力，锁定了五个重点研发领域，包括免疫/感染、泌尿、肿瘤、神经科学和糖尿病合并症/代谢性疾病。
在2010财务年度 (2010 年 4 月至 2011 年 3 月) 全球净销售额达 9539 亿日元（97 亿美元）。安斯泰来已经成为日本第二大处方药品公司，全世界排名 20位的制药企业。目前全球员工约 16000 人。 如欲了解更多详细信息，请登录安斯泰来集团全球网站***********************/en/。

安斯泰来中国介绍：
安斯泰来制药（中国）有限公司（以下简称“安斯泰来中国”）是由原“山之内制药（中国）有限公司”于2005年8月更名，再于2007年4月1日，与“藤泽药品（中国）有限公司”合并而成。
安斯泰来中国以“通过提供创新而可靠的医药产品为世界人民的健康做贡献”为经营理念，秉持高度的伦理观和道德观，开展合乎法规的经营活动。在提升企业价值的使命下，发挥创造性，实现业务的持续发展，力图在中国成为受到客户、员工、相关企业、社会团体等利益相关者信赖的企业。
安斯泰来中国是安斯泰来制药集团在中国投资的全资子公司。工厂位于沈阳经济开发区，总部设在北京，在上海、北京、广州、成都、武汉、青岛和沈阳设有分公司，业务范围遍及全国大中城市，全国约有员工1000名。
安斯泰来中国目前在中国上市销售9个产品，涉及器官移植、泌尿、感染、皮肤、消化循环等多个专业领域，其中已经在器官移植和泌尿领域得到广大医生和患者的认可，处于市场领先地位。如欲了解更多详细信息，请登录安斯泰来中国网站**************************.