Zixian Tang Email & Phone Number

Singapore

Singapore

Singapore

Singapore

Singapore

• Develop submission strategy and coordinate submissions to Regulatory Agency, Central Independent Ethics Committee, and other central or country level authorities to achieve timely start-up• Prepare and QC review country submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements• Create / review Master IMP labels, and coordinate development of country-level labels in adherence with Annex 13 or applicable regional requirements• Support Business Development with regulatory input on Request-for-proposals as required

Singapore

On assignment to GlaxoSmithKline• Supports data management activities for regulatory activities for both planning and tracking in the Regulatory Planning Database (RPD, SharePoint), Regulatory Tracking System (RTS, TrackWise) and Change Control (SENTRY, TrackWise)• Supports document management activities for regulatory documentation, document life-cycle maintenance within the electronic document management (ATLAS and ATLAS Submissions, Livelink; Regulatory Affairs Correspondence Repository (RACoR, SharePoint) and paper copies) as well as metadata associated with such documentation and archiving per applicable procedures• Assists in document formatting, style and link checking, preparing paper submissions, maintaining packaging materials, preparing agency forms and general proofreading• Contributes and actively participates in IT and Business Process Improvement projects to enhance technical functionalities of the systems and in the execution of technical validation tests to verify the correct implementation of system functionalities in compliance with regulatory and business requirements • Provides support to system users to generate and format reports for routine or ad-hoc purposes• For clinical studies essential documents (e.g. clinical study protocols, investigator’s brochures) conducts technical editorial quality checks (formatting, style, compliance with Regulatory Style Guide requirements) and completeness/correctness checks of metadata assigned to final documents prior to their approval and release into the electronic Trial Master File

Singapore

On assignment to Novartis Vaccines and Diagnostics• Supports data management activities for regulatory activities for both planning and tracking in the Regulatory Planning Database (RPD, SharePoint), Regulatory Tracking System (RTS, TrackWise) and Change Control (SENTRY, TrackWise)• Supports document management activities for regulatory documentation, document life-cycle maintenance within the electronic document management (ATLAS and ATLAS Submissions, Livelink; Regulatory Affairs Correspondence Repository (RACoR, SharePoint) and paper copies) as well as metadata associated with such documentation and archiving per applicable procedures• Assists in document formatting, style and link checking, preparing paper submissions, maintaining packaging materials, preparing agency forms and general proofreading• Contributes and actively participates in IT and Business Process Improvement projects to enhance technical functionalities of the systems and in the execution of technical validation tests to verify the correct implementation of system functionalities in compliance with regulatory and business requirements • Provides support to system users to generate and format reports for routine or ad-hoc purposes• For clinical studies essential documents (e.g. clinical study protocols, investigator’s brochures) conducts technical editorial quality checks (formatting, style, compliance with Regulatory Style Guide requirements) and completeness/correctness checks of metadata assigned to final documents prior to their approval and release into the electronic Trial Master File

Singapore

On assignment to Novartis Vaccines and Diagnostics•Support end users in entering data into CTMS by running training, refresher training and addressing queries and issues. •Set up and maintain master data in CTMS, as requested by users. •Perform data quality checks in CTMS to ensure data is consistent, complete and accurate •Liaise with the appropriate teams and managers when procedural/technical issues are encountered, to address and achieve resolution. Liaise with the CTMS Vendor and IT department as required. •Provide orientation and guidance on CTMS processes to regional users •Be knowledgeable and familiar with monitoring activities processes and procedures to ensure best usage and user end support for CTMS applications for regional users •Interact with internal teams from various departments to ensure quality of service •Assist in process improvement •Attend team/system board meetings •Provide support to regional users in running system reports •Support regional users of the CTMS system by explaining the system’s functionalities and helping them overcome issues and hurdles. •Provide day-to-day support to users including answering queries, troubleshooting, and acting as the first escalation point for system functionality. • Support System Testing and Validation

Singapore

Training• Conduct Face-to-Face / Remote end user training, equiping them with the skills to fully utilize NVD ClinTrack (CTMS) system• Provide orientaiton and guidance on system SOP, Work Instructions and related processes• Develop and update training materials for global usersSupport• Sole regional helpdesk (Asia Pacific, Australia, Africa) supporting on CTMS, MySites and Business Objects Web Intelligence• Support regional study planning / setup in CTMS• Setup/maintain user accounts • Maintain system master data• Support global helpdesk as requiredSystem Development• Regional point-of-contact collecting user request for system enhancements• Provide input on impact analysis from business/operational perspective• Propose technical inputs/solutions to meet business/operational requirements• Draft and OQ & PQ validation documents• Conduct informal stress testing as well as formal OQ & PQ validation testing• Develop Training Materials and conduct global training on regular release of system enhancementsBusiness Analytics• Identify and provide pre-built Business Objects reports best suited to user needs• Ensure data completeness and timely update of study information/milestones• Extract and analyze data for management Communications• Develop and distribute Clinical Systems quarterly newsletter - ClinTracker