eCOA / eDC Clinical Data Programmer

• Location: Indianapolis, IN
• Duration: 6 months
• GBaMS ReqID: 10911252
• Role: eCOA / eDC Clinical Data Programmer

Role Responsibilities

• Gather and influence eCOA design specifications to enable successful clinical trial implementation.
• Program and test data collection systems for clinical trials and associated data repository mappings.
• Utilize data standards library components to support trial data collection and mapping.
• 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 Plans.
  • Project Plans.
  • Clinical databases.
  • Observed datasets.
• Support clinical trial submission, inspection, and regulatory response activities.
• Lead complex cross-Business Unit and Therapeutic Area projects or programs.
• Analyze and implement post-production changes to study designs.
• Support clinical data analytics and visualization activities.

eCOA / eDC / eSource Experience

• Hands-on programming experience with:
  • eCOA (electronic Clinical Outcome Assessment).
  • eDC (electronic Data Capture).
  • eSource.
  • Direct Data Capture.
• Design electronic Case Report Form (eCRF) screens for clinical data collection.
• Build and implement required data validations.
• Interpret clinical protocols and clinical terminology to create technical and functional specifications.
• Apply knowledge of clinical data collection workflows, tools, technologies, testing, and system validation.
• Understand clinical data acquisition and aggregation processes.
• Analyze the impact of study design changes and implement required post-production updates.

Data Architecture & Analytics

• Articulate the flow of clinical data from patient collection through analysis.
• Understand clinical data structures and formats.
• Apply data-flow knowledge to clinical data solutions.
• Determine appropriate technology platforms, systems, and databases for data acquisition and aggregation.
• Perform data analytics and visualization activities.
• Work with relational and non-relational database technologies.
• Apply SQL, data functions, and database procedures.
• Experience with database technologies such as MongoDB.
• Strong understanding of data mapping and database structures.

Programming Languages & Technologies

• HTML.
• CSS.
• JavaScript.
• Node.js.
• JSON.
• SpEL.
• SQL.
• Data Functions and Procedures.
• MongoDB.
• GitLab utilities.
• Data mapping technologies.
• Clinical data systems and repositories.

Technical Skills

• Strong technical proficiency in HTML and web technologies.
• Experience developing and maintaining data mappings.
• Strong understanding of database structures and data relationships.
• Experience handling GitLab utilities and version control workflows.
• Ability to quickly learn and adopt emerging technology trends.
• Experience with testing and validation of clinical data collection systems.

Leadership & Collaboration

• Demonstrated leadership experience in a professional environment.
• Lead complex projects and programs across Business Units and Therapeutic Areas.
• Excellent written and verbal communication skills.
• Strong interpersonal and stakeholder management skills.
• Demonstrated teamwork and collaboration in professional settings.
• Ability to work effectively with Clinical Build Programmers, Data Management teams, technical teams, and business stakeholders.
• Strong ability to communicate technical concepts clearly to both technical and non-technical audiences.