Clinical Data Scientist (职位编号：53319434)
和记黄埔医药（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(非欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2022-06-26
- 工作地点：上海-浦东新区
- 工作经验：3-4年经验
- 学历要求：本科
- 职位月薪：2-2.5万
- 职位类别：临床数据分析员
职位描述
KEY ACCOUNTABILITIES
Responsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: perform data management activities in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of data management work contracted to a CRO, perform data integrity review.
The Clinical Data Scientist is accountable to:
？ Provides early input into protocol design, contracting process focused on data management issues;
？ Oversee the process and quality of data management work contracted out to a CRO or research collaborator. Be responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals
？ Proactively communicates with project team to share project status, risk assessment and outstanding item resolution status. Ensures compliance to standard key performance indicators according to process
？ Leads the development of eCRFs, database and all the other DM activities for the study handled internally by interacting with other functional area representatives;
？ Ensure the TMF maintenance of Data Management is on time with good quality.
？ Continually evaluates data management processes and applications for improvements.
Complexity:
？ Understand conceptual basis for data management conventions, standards and processes.
？ Anticipates problems, issues, and delays, and proactively works to minimize the impact.
Specialised Knowledge:
？ Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical, Inform, RAVE) and understanding of database/programming concepts.
？ Knowledge of the clinical development process.
？ Knowledge of industry standards and practices, e.g. CDISC.
Minimum Requirements:
？ Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
？ At least 3-year data management experience in pharmaceutical company or Clinical Research Organization (CRO)
？ Fluent oral and written English skills
Preferred Requirements:
？ Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology
？ Able to work under pressure and in a changing environment with flexibility
？ Good communication skills with the ability to communicate with both the technical and business areas.
Responsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: perform data management activities in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of data management work contracted to a CRO, perform data integrity review.
The Clinical Data Scientist is accountable to:
？ Provides early input into protocol design, contracting process focused on data management issues;
？ Oversee the process and quality of data management work contracted out to a CRO or research collaborator. Be responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals
？ Proactively communicates with project team to share project status, risk assessment and outstanding item resolution status. Ensures compliance to standard key performance indicators according to process
？ Leads the development of eCRFs, database and all the other DM activities for the study handled internally by interacting with other functional area representatives;
？ Ensure the TMF maintenance of Data Management is on time with good quality.
？ Continually evaluates data management processes and applications for improvements.
Complexity:
？ Understand conceptual basis for data management conventions, standards and processes.
？ Anticipates problems, issues, and delays, and proactively works to minimize the impact.
Specialised Knowledge:
？ Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical, Inform, RAVE) and understanding of database/programming concepts.
？ Knowledge of the clinical development process.
？ Knowledge of industry standards and practices, e.g. CDISC.
Minimum Requirements:
？ Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
？ At least 3-year data management experience in pharmaceutical company or Clinical Research Organization (CRO)
？ Fluent oral and written English skills
Preferred Requirements:
？ Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology
？ Able to work under pressure and in a changing environment with flexibility
？ Good communication skills with the ability to communicate with both the technical and business areas.
职能类别：临床数据分析员
公司介绍
和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。
和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。
和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。
和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。
和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。
联系方式
- Email：hr@hmplglobal.com
- 公司地址：和记黄埔医药创新药生产基地