天津招聘

职位描述：
The responsibilities of the Sr. Specialist of Data Management include, but are not limited to:
？ Provides eCRF completion guidelines and gives support to SM, LTM and GTM in helping sites resolve data issues. Provides data flow diagram and sets up data transfer agreements with external data providers. Attends clinical working group meetings of the trial(s) to give data management status updates.
？ Works together with QS colleagues to setup eCRF and data standards. Builds in data quality control steps for the purpose of data analysis.
？ Provides QC oversight plan and other document templates to CRO. Performs quality control
review on all DM documents such as data management plan, eCRF completion guidelines, data flow diagram, and data review guidelines, etc.
Assists in trial level oversight on the clinical trial set-up process and performs/assists on the trial data content and data structure quality control from trial conduct until database lock.
Reviews all deliverables and quality standards for outsourced DM tasks and approves if assigned.
？ Assists the DM CRO in setting up data transfer agreements with external data providers if assigned.


KEY PERFORMANCE INDICATORS
？ Quality of study data for clinical studies.
？ Smoothness of trial conduct in terms of data management.
？ Collaborative, supportive and flexible
EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE REQUIREMENTS
QUALIFICATIONS, EXPERIENCE & SKILLS
？ Bachelor/Master or above degree in a scientific discipline or health related field.
？ Full understanding of relevant regulatory guidelines, GCP and international guidelines regarding data management.
Basic understanding of the clinical drug development process in the pharmaceutical industry Familiarity with DM systems e.g. Medidata Rave, ClinTrial？？ , InForm？？ Basic understanding of current industry standards (CDISC, SDTM, CDASH...) and of technology platforms for data exchange.
？ Requires1- 3 years of experience previously in data management and in clinical drug development in the pharmaceutical industry.
？ Diligent and serious, precise thinking, strong sense of responsibility and accountability. Results and performance driven, sense of urgency. Team spirit, attention to details and good self-motivated.
？ Good written and verbal communication skills in Chinese and English. 举报 分享

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.