Everest Clinical Research

Software Engineer

• Develop and review SDTM and ADaM dataset specifications, annotated CRFs, define.xml, reviewer’s guides, and related documents
• Program and validate SDTM and ADaM datasets
• Perform CDISC conformance checks and address findings
• Develop SAS programs for statistical output reports based on SAP and TLG mock-up shells
• Provide programming support for Clinical Study Reports, integrated safety and efficacy analyses, regulatory safety reports, ad-hoc requests, and exploratory analyses
• Develop and maintain SAS programs for database integrity checks and ongoing data cleaning
• Reconcile CRF and non-CRF data and perform non-CRF data integrity checks
• Generate data listings, summary tables, graphs, and Patient Profiles
• Document data and programming information according to SOPs and WIs
• Achieve audit readiness and defined statistical programming performance indicators
• Maintain knowledge of industry standards and regulatory requirements
• Develop and provide expertise in other programming and system administration areas when required

Statistical Programmer II

Designer

• Design clinical databases for new studies in various electronic data capture (EDC) systems, including CRFs, edit checks, study roles, laboratory, coder, and RTSM
• Perform post-go-live database modifications and provide impact assessments
• Perform unit testing, assist user acceptance testing, and address UAT findings
• Set up and configure development environments for new studies
• Assist with Database Integration Specifications, provide Integration Technical Details, program integrations, and assist integration testing
• Support Data Managers in investigating and addressing database design issues
• Assist study decommissioning and archiving
• Develop database design features and functionality to improve study-level efficiency and company capabilities
• Review study design specifications for EDC platform and Everest standards compliance
• Review protocols and reference materials to ensure database design specifications meet protocol requirements
• Contribute to database design project timelines and maintain database design timelines
• Assist Clinical Data Management in planning, directing, and managing database design and maintenance
• Follow regulatory requirements, industry trends, benchmarking, and best practices in data management and database design
• Participate in EDC vendor technical learning and exchange meetings and other training meetings
• Contribute to database design procedures, work instructions, checklists, and templates
• Provide input to database design-related data management procedures
• Cooperate with Quality Assurance on quality control audits
• Validate and disseminate real-time study monitoring reports to sponsors and internal team members
• Participate in Clinical Data Management initiatives

Senior Clinical Database Designer I

Clinical Research

• 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

Senior Clinical Data Manager

• Lead resolution of day-to-day work-related issues and problems
• Ensure quality of deliverables and improve statistical programming efficiency and productivity
• Lead assigned projects using project management skills and statistical programming techniques
• Deliver high-quality project deliverables on time and build client trust and repeat business
• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE
• Perform QC reviews of dataset specifications prepared by others
• Program and validate SDTM and ADaM datasets
• Perform CDISC standard-compliant checks on SDTM and ADaM datasets
• Generate, review, and resolve Pinnacle 21 validation issues
• Perform additional QC checks using company Working Instruction checklists
• Review statistical TLGs for overall quality and consistency before internal or client delivery
• Create and QC define.xml files
• Participate in or lead programming teams supporting regulatory submission activities
• Maintain expertise in statistical programming utilities and macros
• Develop new macros and utilities
• Program and perform QC/validation of complex data integrity checks for data quality and scientific data surveillance
• Complete job-required and project-specific training
• Comply with Everest and trial sponsor policies, SOPs, and WIs
• Document data and programming information according to corporate SOPs and guidelines
• Archive SDTM and ADaM datasets and programming information according to archival SOPs and guidelines

Senior Statistical Programmer

• Design clinical databases for new studies in various electronic data capture (EDC) systems, including CRFs, edit checks, study roles, laboratory, coder, randomization, and trial supply management
• Perform post-go-live database modifications and impact assessments
• Perform unit testing, assist with User Acceptance Testing, and address UAT findings
• Conduct quality-control reviews of databases designed by other designers
• Set up and configure development environments for new studies
• Create Database Integration Specifications, provide integration technical details, and assist with integration and testing
• Support Data Managers in investigating and resolving database-design issues
• Assist with study decommissioning and archiving
• Develop database-design features and functionality to improve study-level efficiency and company capabilities
• Mentor and guide new Database Designers on procedures and best practices
• Review study design specifications and protocols for EDC and Everest standards compliance
• Contribute to and maintain database-design project timelines
• Assist Clinical Data Management with planning, directing, and managing database design and maintenance
• Monitor regulatory requirements, industry trends, benchmarking, and data-management best practices
• Participate in EDC vendor technical meetings and training
• Develop and maintain database-design procedural documents, work instructions, checklists, guides, and templates
• Assist Quality Assurance with QC audits on assigned databases
• Validate and disseminate real-time study monitoring reports to sponsors and internal team members
• Participate in Clinical Data Management initiatives

Senior Clinical Database Designer – II

• 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

Head of Department

• Develop and execute a global clinical operations delivery strategy aligned with corporate growth and operational objectives
• Establish a vision for clinical delivery excellence across all regions
• Define organizational priorities, resource investments, and transformation initiatives with executive leadership
• Drive process improvement, technology adoption, and innovative operating models
• Represent Global Clinical Delivery in executive governance forums and strategic customer engagements
• Provide executive oversight of Phase I–IV clinical operations and full-service trial delivery
• Ensure studies are delivered on time, within budget, and in compliance with regulatory and quality requirements
• Establish delivery standards, governance models, and performance expectations
• Monitor portfolio performance and resolve critical delivery risks and issues
• Oversee global clinical operations and full-service client portfolio, resource allocation, and risk mitigation
• Drive accountability for quality, timelines, enrollment, site performance, and study outcomes
• Ensure cross-functional alignment across clinical, data management, biostatistics, regulatory, medical writing, safety, and other teams
• Lead executive-level escalation management for critical studies and strategic customers
• Build executive relationships with sponsors and strategic partners
• Represent clinical delivery in business development, proposal reviews, and bid defenses
• Support customer retention, expansion opportunities, and new business acquisition
• Serve as executive sponsor for key accounts and resolve significant customer concerns
• Own revenue realization, profitability, forecasting accuracy, and operational efficiency
• Manage study budgets, scope changes, resourcing models, and client commitments
• Establish KPIs and operational metrics
• Lead, mentor, and develop a high-performing global clinical delivery organization
• Build leadership capability, succession plans, and talent pipelines
• Foster collaboration, innovation, diversity, inclusion, and continuous professional development
• Drive employee engagement, retention, and workforce planning
• Ensure compliance, inspection readiness, audit support, and proactive risk management