eCOA Build Programmer

Talent Technical Services, Inc

15 hours ago

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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

Design, program, and testclinical trial data collection databases.
Perform mapping, testing, and normalization of data into aclinical 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 influenceeCOA design specifications for successful trial implementation.
Program and test data collection systems and associateddata repository mappings.
Usedata 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 withClinical Build Programmers to ensure complete data builds.
Provide insights into study-level deliverables, including:
- Data Management Plan
- Project Plan
- Database
- Observed datasets
Supportsubmission, inspection, and regulatory response activities.
Lead complex cross-Business Unit / Therapeutic Area projects and programs.

Hands-on programming experience with:
- eCOA (electronic Clinical Outcome Assessment)
- eDC (electronic Data Capture)
- eSource
- Direct Data Capture
Design electronicCRF screens for clinical data collection.
Build required validations and edit checks.
Understand and interpretclinical 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 implementpost-production study design changes.
Performdata analytics and visualization.
Understand and articulate the complete data flow frompatient to analysis, including data structure and format.
Apply data-flow knowledge to develop appropriate data solutions.
Determine appropriatetechnology platforms, systems, and databases for data acquisition and aggregation.

Review:
- Clinical protocols
- eCOA requirements
- Instrument specifications
- Translations
- Visit schedules
- Edit-check requirements
Determine the overallstudy 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.
Maintainend-to-end requirements traceability.
Prepare and maintain:
- Build specifications
- Configuration documentation
- Test scripts
- Validation evidence
- Release notes
- Deployment records
Conductunit 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

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.

Coordinate study build activities acrossonsite 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.

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

eCOA Build Programmer · Talent Technical Services, Inc