成都招聘

岗位描述：

Plans, executes and completes the study/project related DM activities in studies/projects on time, within budget, and with high quality, consistent with company quality and compliance standards;
Support the set-up and maintains DM outsourcing and oversight model
o Assesses/supports to assess DM vendor contracts including budget estimates;

o Collaborates with internal staff and vendors to monitor data management work and ensures delivery of milestones to include data capturing form and specifications, data display, data cleaning, database lock, and data reporting that meet pre-defined expectations and regulatory requirements;

Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
Designs and/or reviews eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans, Data Quality Control Plan, detailing complete data management processes throughout clinical studies; Create/Oversee development of data edit check specifications and manual data listings.
Responsible/oversee for data cleaning, query and resolutions, review of medical coding, database lock activities; Responsible/oversee for lab reconciliation, manage and reconcile external data, authoring data transfer agreements, and ensuring study documentation to be filed in the eTMF
Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation. 
Provide support and information to functional areas such as clinical monitoring, medical physicians/medical affairs, and statisticians.
Monitor work productivity or quality to ensure compliance with standard operating procedures.
Manages risks: responsible for anticipation, prevention and early detection of issues impacting DM deliverables. Coordinates real time inspection readiness for all DM deliverables as necessary.

任职要求：

5-8 years or above of working experiences in clinical data management in pharmaceutical or biotechnology industry.
Education /Training background:Bachelor, Master or above degree in a scientific discipline or health related field. 
Knowledge/Skills: Possesses solid computer system and technical skills with a strong ability to learn multiple e computer applications. 
Prior experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards are desirable.
o Understanding of relevant regulatory guidelines and GCP

o Understanding of the clinical development process in the pharmaceutical industry

o Familiarity with DM systems e.g. CTMS, Medidata Rave, InForm

o Successful completion of multiple trials from beginning to end providing a full scope of DM experiences

Diligent and serious, precise thinking, strong sense of responsibility. Operates and executes with limited supervision.Good/Excellent written and verbal communication skills in Chinese and English.

亿腾医药是一家综合性的医药公司。我们的愿景是凭借我们经市场验证的完整价值链能力，成为专注于抗感染、心血管疾病及呼吸系统三个核心治疗领域“放眼全球、服务中国”的医药公司。

一方面，我们致力于不断引入全球优质医药资源，拥有具有国际竞争力的生产设施和全球供应链，采用国际标准的运营管理，且领导团队具备国际视野；另一方面，经过近二十年的不断探索，我们凭借对中国市场的深刻洞见，构建起规模化的高效商业化平台和高标准的本土生产基地，并取得优异的运营表现。

我们相信“放眼全球、服务中国”的双轮驱动模式，能帮助我们更好地服务中国市场，为患者持续提供优质的全球医疗产品和服务。