Clinical Research

• Ensure completeness, quality, and integrity of clinical data in the database
• Perform, oversee, and be responsible for development of data management documents
• Conduct database UAT and quality control
• Perform data cleaning and query management activities
• Act as a subject matter expert for one or more specific Data Management tasks
• Assist in developing and implementing new technologies and department tools
• Mentor and train Data Managers
• Provide new project recommendations, attend bid defense meetings, and prepare for project interviews
• Author and maintain eCRF specifications and Data Validation Plans
• Develop and maintain Data Management Plans, eCRF completion guidelines, and SAE reconciliation plans
• Manage local lab workflows, SAE reconciliation, and external data reconciliation
• Track and report study metrics
• Establish study timelines for data snapshots, database freeze/lock, and quality deliverables
• Attend data review meetings when applicable
• Archive Data Management documentation
• Manage study timelines and estimate resource requirements
• Manage project budgets, scope, work completed, and revenue forecasts
• Update PDMS and handle project finance-related issues

Clinical Data Manager

• Plan, manage, control, and perform data processing and management activities for assigned projects
• Lead data processing and management projects using project management skills and data management techniques
• Manage timelines and coordinate activities for assigned projects
• Specify and maintain database validation checks for assigned studies and therapeutic/drug-area modules
• Define and monitor clinical trial dataflow and quality control processes according to SOPs, Good Working Practices, and unit guidelines
• Train clinical trial site monitors on dataflow and QC processes
• Design and review patient Case Report Forms and database schemas
• Test data capture and entry screens
• Validate electronically captured data
• Write queries for missing data and data failing range or logical checks
• Build and maintain standard query libraries
• Perform QC during trials and database closure checks at study completion
• Train and supervise Data Entry personnel and junior data management personnel
• Validate and distribute study progress status reports to internal and external study team members
• Assist in resolving data coding discrepancies
• Prepare data management documentation for final archival and assist with archiving clinical trial data and study documentation
• Assist data management QA personnel with QA procedures on trial CRFs, database schemas, and databases

Clinical Data Manager I

• Develop and maintain Data Management Project Plans and document deviations
• Lead day-to-day data management activities and own deliverables for assigned projects
• Manage data management timelines, deliverables, status reporting, project planning, progress tracking, and reporting
• Serve as primary contact for data management communications, deliverables, out-of-scope requests, and technical or procedural issues
• Assist with study-level resource planning, team member timesheet review, client relationship management, bid defense meetings, Work Orders, and Amendments
• Train clinical trial personnel on EDC systems, dataflow, and quality control processes
• Train new data management personnel on processes and procedures
• Perform quality-control reviews of less experienced personnel’s work
• Manage third-party vendor dataflow and performance
• Participate in project kick-off, investigators, and project management team meetings
• Support client audits and regulatory inspections and follow up on findings
• Create and maintain clinical trial Data Management Study Binders
• Design and review CRFs/eCRFs, completion instructions, annotated CRFs, and source document templates
• Develop and maintain data validation specifications, Data Management Plans, and Data Quality Review Plans
• Participate in database design and EDC User Acceptance Testing
• Manage post-go-live database modifications
• Coordinate programming and validation of listings and summary tables
• Review data, issue and resolve queries, and assist investigative sites with query resolution
• Perform Serious Adverse Event reconciliation and assist with medical coding discrepancies
• Support quality control audits on assigned databases
• Perform database soft-lock and hard-lock activities
• Prepare final archival of data management documentation and assist the corporate archivist

Clinical Research jobs in Taiwan

Clinical Data Manager

Clinical Data Manager I

Senior Clinical Data Manager