* Produce standard and custom reports for use by the Clinical Data Managers in their data review and cleaning efforts, develops transfer specifications with vendors for external data sources, and performs Study Data Tabulation Model (SDTM) conversion programming and Quality Control (QC).
* Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.
* Program reports and listings as requested by project team members for ongoing studies.
* Responsible and accountable for the development, implementation and delivery of the clinical development strategy in line with Global Development Plan
* Ensure the project management in alignment with the established organisational objectives
* Build the Japan development plan in collaboration with Japan and global development teams and stakeholders
* Lead the project team to obtain the endorsement from governance body
* Develop project time-line in line with strategy and plan of the project
* Provide oversight of project st ...
* Produce an manage SAS are met within the allocate timeline
* Produce SASSAS programs and documents (e.g. specifications and mock shell) to deliver the tables, listings, figures (TLFsTLFs), Study Data Tabulation Model (SDTMSDTM) and Analysis Data Model (ADaMADaM) based on agreement with user representative.
* Produce accordingly define.xml, Study Data Reviewer's Guide (SDRG), Analysis Data Reviewer's Guide (ADRG) and Analysis Results Meta data (ARM).
* Lead, contribute and/or support from the aspects of the Programming field ...
* Protocol development and clinical strategy within immunology and neuroscience
For the assigned program/project(s) in the region with support by function head / seniors:
Assume overall responsibilities as a regional/country level Development Team leader in the matrix setting to ensure alignment across key stakeholders and promote team work.
Drive the development of Clinical Development Plan (CDP) and relevant study designs through team effort; ensure input from internal or external expertise is integrated and ...
* Responsible for Reviewing Trial Protocol, CRF Design and Trial Data Base Set Up
* Initiates and Compiles the Trial Data Management Plan for all Assigned Trials
* As a Trial Data Manager(TDM), reviews the trial protocol, designs the Case Report Forms (CRF), sets up the trial database and defines and programs the plausibility checks based on project standards and additional trial requirements as needed. Together with the Clinical Trial Lead (CTL) and the Trial Statistician(TSTAT), the TDM initiates and compiles the Trial Data Man ...
* As a member of trial team, provide and maintain oversight and guidance related to site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.
Ensure delivery of clinical trials (from trial preparation to trial closure and reporting) in terms of
Deliver site monitoring approach for the trial
* Develop Tri ...
* Responsible for managing project life cycle, including discussions with clients, development of project specifications, documentation of project set up, coordination with overseas technical operations team, and management of all project related activities through to project completion.
* Act as primary point of contact to clients, communicate effectively and build/maintain relationships.
* Leads the customization of key control documents (e.g., project plans, communication plans, project governance structure, etc.)