上海招聘

Role Description:
Accountable for data management for all assets in the corresponding clinical development programs.

Key Objectives/Deliverables:
1. Define corporate DM strategy.
2. Fully participate in CRO DM service vendor selection and provide comment from cost-effective perspective (including technique and budget, etc.) during the CRO DM service vendor selection and EDC platform selection.
3. Manage DM service vendors and oversee their performance to drive the study/project level data management deliverables and all analysis and regulation requirement are met.
  a) Oversight CRO DM on database set up, freeze and lock processes and procedures.
  b) Ensures and oversight CRO DM deliverable quality includes: user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding.
  c) Oversight CRO DM to perform schedules and requests data transfers/imports/exports to/from CRF/eCRF database and associated databases.
  d) Reviews and approves if deemed necessary:
      i. Project plans and guidelines for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF/eCRF completion and other applicable project plans;
      ii. Specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources;
      iii. Output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.
  e) Ensures that all applicable documents and databases (data sets) are archived or returned to the company from CRO DM appropriately.
4. Be accountable for discussing, managing the risk and providing the solution to the critical findings during study startup and conducting period with Medical, Clinical Operation and other function teams.
5. Be responsible for building up a functional DM team in late stage.

6. Ensure the continuity and consistency of DM operation given vendor switch or DM operating model change

7. Other activities based on work arrangement

Basis Requirements:
1. BA/BS or above degree in the biological sciences or related disciplines in the natural science/health care field.
2. At least 10 years' working experience in DM, at least 5 years working in multi-national pharmaceutical companies. At least 5 years experiences in people management. Experience in global CRO is a plus.
3. Participated in numbers of Phase I to III clinical trials, be familiar with the whole process of data management and get rich experience in Clinical Data Management practices and relational database management software systems.
4. Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
5. Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
6. Effective oral and written communication skills both in English and Chinese.
7. Good organizational, planning, and time management skills with the ability to make effective decisions and manage multiple priorities in a highly dynamic environment while providing attention to detail.

8. Flexible, capable of adapting to change and work independently, as well as part of a multi-disciplinary team. 

公司背景

和其瑞医药是一家科学驱动的临床阶段生物制药公司，在中国北京、上海和南京设有办公室。公司的创立是基于北京大学分子医学研究所（IMM）肖瑞平教授和她的团队对人体生物学和转化医学的深入理解与研究，依托北京大学分子医学研究所南京转化基地而生。南京转化基地是北大分子医学研究所团队携十多年潜心研究的创新成果，落户南京江北高新技术开发区建设而成，该基地将围绕“重大疾病创新药物”和“高端生物医学成像装备”两大研发方向，与北京大学分子医学研究所无缝衔接，和其瑞医药即作为基地“重大疾病创新药”研发方向的主力孵化企业之一。肖瑞平教授和娄实先生为公司联合创始人，肖瑞平教授任公司董事长和CEO，娄实先生任董事兼首席运营官。和其瑞致力于研究、开发和商业化***新药，针对流行广泛的***和***疾病，以改善生命质量为目标。目前和其瑞医药有限公司已宣布完成A轮融资，并宣布与拜耳公司（Bayer AG）就开发与产业化靶向泌乳素（PRL）受体的单克隆抗体签署一项全球独家许可协议。
依照许可协议，和其瑞医药将基于拜耳的知识产权，在全球开展靶向泌乳素（PRL）受体的全新抗体的开发和产业化。该抗体的潜在适应症包括***与***脱发症（*** and *** pattern alopecia），子宫内膜异位症（endometriosis），以及其它慢性疾病。泌乳素（PRL）受体抗体是靶向泌乳素受体的单克隆抗体，以非竞争性抑制的方式阻断泌乳素下游的信号通路。给药方式为皮下注射。该抗体I期临床试验中表现出良好的耐受性（包括单剂量和多剂量给药）。
同时研究发现这一抗体能有效促进老年红面猴头发的生长，在治疗6个月后，脱发区终末毛发的数量增长了近一倍，即使是之前近乎完全秃顶的区域，且疗效持续达停药后两年以上。这一研究是拜耳和北大分子医学研究所科学家们紧密合作的成果，未来将有望用于***及***脱发症的治疗。

团队主创人员介绍

肖瑞平（Rui-Ping Xiao）
和其瑞医药有限公司联合创始人，现任公司董事长兼首席执行官，北京大学讲席教授，北大分子医学研究所所长，《新英格兰医学杂志》副主编，曾任美国国立卫生研究院老年研究所终身研究员。

娄实 （Sam Lou）
和其瑞医药有限公司联合创始人，现任公司董事兼首席运营官，先后出任全球领先临床研发服务机构中国区总经理（PAREXEL CHINA DINGHUI），新药研发和CRO公司商务与信息副总裁（中美冠科），CMC副总裁（方达医药）；医疗器械产业化公司CEO（万东康源）。娄实先生是百华协会资深会员，同写意新药英才俱乐部副秘书长。