eCOA Build Programmer

eCOA Build Programmer

• Location: Indianapolis, IN
• Duration: 6 months
• Experience Required: 8–10 years
• Role: eCOA Build Programmer
• Skills: Life Sciences, Clinical Data Management (CDM), Clinical Database Programming, Overview & Study Setup

Core Responsibilities

• Design, program, and test clinical trial data collection databases.
• Perform mapping, testing, and normalization of data into a clinical data warehouse.
• Apply strong knowledge of:
  • Data technology
  • Data flow
  • Data standards
  • Database programming
  • Data normalization
  • Testing and validation
• Collaborate with study teams to deliver standardized data collection methods and innovative validation solutions for global clinical trials.
• Gather and influence eCOA design specifications for successful trial implementation.
• Program and test data collection systems and associated data repository mappings.
• Use data standards library components for trial or program builds.
• Ensure data collection systems and data warehouse mappings are accurate, efficient, and aligned with study objectives.
• Partner with Clinical Build Programmers to ensure complete data builds.
• Provide insights into study-level deliverables, including:
  • Data Management Plan
  • Project Plan
  • Database
  • Observed datasets
• Support submission, inspection, and regulatory response activities.
• Lead complex cross-Business Unit / Therapeutic Area projects and programs.

eCOA / eDC / Clinical Data Experience

• Hands-on programming experience with:
  • eCOA (electronic Clinical Outcome Assessment)
  • eDC (electronic Data Capture)
  • eSource
  • Direct Data Capture
• Design electronic CRF screens for clinical data collection.
• Build required validations and edit checks.
• Understand and interpret clinical protocols and clinical terminology.
• Translate clinical requirements into technical specifications.
• Familiarity with clinical data tools, technologies, and workflows for:
  • Patient data collection
  • Testing
  • System validation
• Analyze impacts and implement post-production study design changes.
• Perform data analytics and visualization.
• Understand and articulate the complete data flow from patient to analysis, including data structure and format.
• Apply data-flow knowledge to develop appropriate data solutions.
• Determine appropriate technology platforms, systems, and databases for data acquisition and aggregation.

eCOA Study Build Responsibilities

• Review:
  • Clinical protocols
  • eCOA requirements
  • Instrument specifications
  • Translations
  • Visit schedules
  • Edit-check requirements
• Determine the overall study build scope.
• Configure and program eCOA studies, including:
  • Questionnaires
  • Diaries
  • Assessments
  • Visit workflows
  • Notifications
  • User roles
  • Devices
  • Data transfer settings
• Translate approved clinical and business requirements into accurate system configurations.
• Maintain end-to-end requirements traceability.
• Prepare and maintain:
  • Build specifications
  • Configuration documentation
  • Test scripts
  • Validation evidence
  • Release notes
  • Deployment records
• Conduct unit testing.
• Support:
  • System testing
  • Integration testing
  • User Acceptance Testing (UAT)
  • Regression testing
  • Production validation
• Manage defects and change requests.
• Perform impact assessments.
• Troubleshoot configuration and data issues.
• Coordinate issue resolution with platform and vendor teams.
• Work with instrument owners and licensing teams to ensure correct implementation of:
  • Approved content
  • Scoring rules
  • Copyright requirements
  • Language versions

Integration & Data Management

• Support integrations and data transfers between eCOA platforms and clinical systems.
• Experience integrating with:
  • EDC
  • IRT
  • CTMS
  • Data warehouses
  • Analytics environments
• Understand clinical data structures, data mapping, and database architecture.
• Ensure accurate data movement from collection systems through downstream analysis environments.

Programming & Technical Skills

• HTML
• CSS
• JavaScript
• Node.js
• JSON
• SpEL
• SQL
• Data Functions and Procedures
• Relational databases
• Non-relational databases
• MongoDB
• Database structures
• Data mapping
• Clinical data programming
• GitLab utilities
• Data analytics and visualization

Validation, Compliance & Documentation

• Ensure eCOA builds comply with:
  • Standard Operating Procedures (SOPs)
  • Good Documentation Practices (GDP)
  • Validation requirements
  • Data privacy expectations
  • Applicable regulations
• Support regulatory submissions, inspections, and responses.
• Maintain appropriate validation and audit documentation.
• Support production deployment and study go-live.
• Perform post-production verification.
• Support:
  • Maintenance releases
  • Study amendments
  • Study closeout activities

Project & Team Responsibilities

• Coordinate study build activities across onsite and offshore teams.
• Track:
  • Milestones
  • Dependencies
  • Risks
  • Issues
• Provide clear status updates to stakeholders.
• Demonstrate strong leadership in a professional environment.
• Demonstrate strong teamwork and collaboration.
• Communicate effectively with technical and business stakeholders.
• Work effectively with cross-functional teams, instrument owners, vendors, and licensing teams.
• Lead complex cross-functional projects and programs.

Continuous Improvement

• Contribute to reusable:
  • Templates
  • Standards
  • Automation
  • Peer-review processes
• Identify opportunities to improve eCOA study build processes.
• Quickly learn and adopt new technology trends.
• Support standardization and continuous improvement initiatives.

Essential Skills

• eCOA Build Programming
• eCOA / eDC / eSource / Direct Data Capture
• Clinical Database Programming
• Clinical Data Management
• Clinical Trial Data Collection
• Electronic CRF Design
• Clinical Protocol Interpretation
• Data Mapping
• Data Normalization
• Database Programming
• HTML / CSS / JavaScript
• Node.js
• JSON
• SpEL
• SQL
• MongoDB
• GitLab
• Data Analytics & Visualization
• Clinical Data Integration
• System Testing & Validation
• UAT / Regression Testing
• Clinical Data Warehouse
• EDC / IRT / CTMS Integration
• Life Sciences / Clinical Research
• Regulatory & Validation Requirements