Responsible and accountable for managing all Data Management deliverables with respect to cost, quality and timelines for all assigned programs, indications or trials managed within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.

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

Education (minimum/desirable): University or college degree in life science, computer sci- ence, pharmacy, nursing or equivalent relevant degree.

Languages: Fluent English, Chinese (oral and written).

Experience/Professional requirement:

experience in Drug Development Clinical Data

Management