eCOA / Clinical Data Systems Programmer

Location: Indianapolis, IN
Duration: 6 months
GBaMS ReqID: 10911252

Role Responsibilities

• Gather and influence eCOA design specifications to enable successful clinical trial implementation.
• Program and test data collection systems and associated data repository mappings for:
  • Individual trials
  • Trial programs
• Utilize data standards library components for data collection and mapping activities.
• Ensure data collection systems and data warehouse mappings are:
  • Accurate
  • Efficient
  • Aligned with study objectives
• Partner with Clinical Build Programmers to ensure complete data builds for trial data collection requirements.
• Provide insights into study-level deliverables, including:
  • Data Management Plan
  • Project Plan
  • Database
  • Observed Datasets
• Support:
  • Regulatory submissions
  • Inspection activities
  • Regulatory response activities
• Lead complex, cross-Business Unit and Therapeutic Area projects or programs.

Clinical Systems & eCOA/eDC 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 data validations within clinical data collection systems.
• Understand clinical protocols and interpret clinical terminology to create and design technical specifications.
• Demonstrate familiarity with:
  • Clinical data tools
  • Clinical technologies
  • Clinical data workflows
  • Patient data collection processes
  • System testing
  • System validation
• Analyze the impact of post-production changes to study designs.
• Implement required post-production study design changes.
• Perform data analytics and visualization.
• Articulate the flow of data from patient to analysis, including:
  • Data structure
  • Data format
  • Data transformations
• Apply knowledge of clinical data flows to develop effective data solutions.
• Determine appropriate technology platforms, systems, and databases for:
  • Data acquisition
  • Data aggregation

Programming & Technical Skills

• Programming experience with:
  • HTML
  • CSS
  • JavaScript
  • Node.js
  • JSON
  • SpEL
• Experience with relational and non-relational database technologies.
• Strong knowledge of:
  • SQL
  • Data Functions
  • Stored Procedures
  • Database structures
• Experience with non-relational databases such as:
  • MongoDB
• Technical proficiency in:
  • HTML
  • Data Mapping
  • Database Structures
  • Data Collection Systems
• Experience working with GitLab utilities.
• Ability to quickly learn and adopt emerging technology trends.

Leadership & Soft Skills

• Excellent leadership skills.
• Strong written and verbal communication skills.
• Excellent interpersonal and stakeholder management skills.
• Demonstrated leadership in a professional environment.
• Strong teamwork and collaboration skills.
• Ability to work effectively across Business Units and Therapeutic Areas.