Emerald Clinical

Clinical Data Coordinator

• Ensure completeness, quality, and integrity of clinical data in the database
• Perform or oversee data management document development
• Perform database UAT and QC activities
• Organize and perform data review and query management activities
• Review local laboratory normal ranges and contact the study team regarding issues
• Perform SAE reconciliation and external data reconciliation
• Generate data status reports
• Perform data quality control
• Archive data management documentation
• Contribute to SOP, process, and system enhancements
• Create and maintain eCRF specifications and Data Validation Plans with guidance
• Create and maintain data management documentation, including Data Management Plans, eCRF completion guidelines, and SAE reconciliation plans

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

Financial Planning and Analysis

• Perform budget uploads, payment schedule updates, and project task uploads in relevant systems
• Support project revenue recognition, forecasting, and budgeting activities
• Assist with project billing and milestone tracking
• Support monitoring of unbilled/unearned revenue and customer advances
• Assist with month-end activities, reconciliations, and journal entries
• Support Budget vs. Actual and Forecast vs. Actual variance analysis
• Maintain accurate project financial data and documentation
• Prepare basic financial reports and analysis
• Coordinate with Project Managers and Finance teams on project financial activities
• Follow established Project Finance processes and controls

Associate Project Finance Analyst

Contracts Specialist

• Prepare, review, negotiate, and manage clinical trial agreements, amendments, and associated contract documentation
• Develop, negotiate, and manage site budgets within approved sponsor parameters
• Liaise with sponsors, investigative sites, legal teams, and internal stakeholders on contract and budget activities
• Ensure contracts and budgets are executed within study timelines and project milestones
• Maintain contract management systems, trackers, templates, and documentation
• Review contractual documents for accuracy, completeness, regulatory alignment, sponsor requirements, and company policy compliance
• Monitor contract status and resolve negotiation roadblocks
• Support site payment activities and coordinate accurate, timely invoicing
• Assist with country and site start-up activities, document collection, and study maintenance
• File and maintain contract-related documentation throughout the study lifecycle
• Participate in project meetings and report contract and budget progress
• Support quality initiatives, audits, inspections, and process improvement activities
• Contribute to development of systems, tools, and best practices for contract and budget management

Site Contracts Specialist

• Prepare, review, negotiate, and manage clinical trial agreements, amendments, and associated contract documentation
• Develop, negotiate, and manage site budgets within approved sponsor parameters
• Liaise between sponsors, investigative sites, legal teams, and internal stakeholders regarding contract and budget activities
• Ensure contracts and budgets are executed within agreed study timelines and project milestones
• Maintain contract management systems, trackers, templates, and documentation
• Review contractual documents for accuracy, completeness, regulatory alignment, sponsor requirements, and company policies
• Monitor contract status and resolve negotiation roadblocks
• Support site payment activities and coordinate accurate, timely invoicing
• Assist with country and site start-up activities, document collection, and study maintenance
• File and maintain contract-related documentation throughout the study lifecycle
• Participate in project meetings and provide contract and budget progress updates
• Support quality initiatives, audits, inspections, and process improvement activities
• Contribute to systems, tools, and best practices for contract and budget management

Medical writer

• Research, write, and edit clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, regulatory submission document sections, and scientific manuscripts
• Apply therapeutic expertise, clinical drug development knowledge, and relevant experience to projects involving drugs, biologics, devices, and other products for human use
• Act as Lead Medical Writer on complex projects such as regulatory submissions, CTD modules, and clinical overviews
• Liaise directly with customers on medical writing issues
• Propose costings for less routine projects, out-of-scope activities, and potential budget efficiencies with manager guidance
• Present on project-specific medical writing proposals at full-service bid defence meetings
• Interpret non-clinical and clinical data in technical reports
• Provide senior review and guidance for documents prepared by junior staff
• Design training materials and contribute to generic training plans
• Deliver general Medical Writing training to internal and external groups
• Act as Project Manager for small series of stand-alone Medical Writing projects
• Monitor current data, trends, medical writing and regulatory knowledge, and drug development advances
• Propose SOP revisions and process improvements; draft and review Medical Writing SOPs

Medical Writer – Senior Medical Writer

General

• Provide day-to-day operational and administrative support to Early Phase Project Managers
• Manage study documentation and maintain project trackers and systems
• Coordinate internal and external project meetings, including scheduling, agendas, and meeting minutes
• Follow up on action items and deliverables with cross-functional teams and vendors
• Support communications with clinical sites, vendors, and internal teams
• Contribute to study start-up, maintenance, and close-out activities
• Ensure activities comply with SOPs, ICH-GCP guidelines, and regulatory standards
• Co-coordinate client, cross-functional internal team, and vendor meetings
• Prepare meeting minutes for internal and external stakeholders
• Assist with study and site budget management, including investigator site payments, vendor payments, and payment tracking
• Maintain the Trial Master File (TMF), including document uploads, quality reviews, and regular reviews for assigned projects
• Support delivery and coordination of global clinical trials

Clinical Data Coordinator

Clinical Data Manager

Associate Project Finance Analyst

Site Contracts Specialist

Site Contracts Specialist

Medical Writer – Senior Medical Writer

Project Specialist, APAC – Mandarin Speaking