天津招聘

职位描述：
Major Activities (Describe 8-12 main activities)
§ Responsible for the Data Management (DM) start-up activities across assigned trials, in- dications or programs including electronic Case Report Form (eCRF) design and genera- tion of the data handling and data review plans
§ Maintains standards within a program/indication
§ Responsible for management and communication for CFDA DM guidance/requirements
§ Align China DM submission processes and standards
§ Responsible for preparing DM submission documents for China CTAs and NDAs
§ Identifies trends in the data and possible solutions for efficiencies
§ With support from Program Clinical Data Manager (PCDM) ensures study conventions, processes, knowledge sharing and best practice exist for all assigned trials
§ Skilled on a range of systems/tools in use by Novartis and by Contract Research Organi- zation (CRO) partners and provide Data Management (DM) oversight to locally funded, registration-related outsourced trails
§ Responsible for ongoing review of data, database maintenance & creation / maintenance of study documentation
§ Ensures the review of listings for quality, content, format and output
§ Responsible for the final review of data and finalization of the study documentation
§ Responsible for the final review of listings for quality, content, format and output
§ Tracks and reports status and progress for assigned trials, indications or programs and proactive to ensure timely deliverables (incl. Snapshots and interim/final locks)
§ Ensures creation of study specific project plans
§ Prepares feedback information about sites query performance and data entry compliance
§ Interacts at International Clinical Teams (ICTs) and Biometrics and Data Management Project Teams as DM consultant for China.
§ Ensures adherence to GCP, DM standards, SOPs/Working Practices (WPs) and process guidelines
§ Able to effectively represent DM in SOP reviews and updates and collaborate with
 global DM to support Data Management process
§ Participates in Health Authority Inspections and assists in responding to requests for in- formation from Health Authorities on DM related topics
§ Responsible for managing all study documents required during a Regulatory (CDA) ,CFDI and internal audit
§ Acts as cross-functional subject matter expert and presents at or chairs forums in areas of expertise
§ Mentors and trains new colleagues and/or other team members as assigned
§ Provides ongoing input on performance of team members to next level manager

Requirements:
University or college degree in life science, computer sci- ence, pharmacy, nursing or equivalent relevant degree.
Fluent English, Chinese (oral and written).
experience in Drug Development Clinical Data Management 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.