Clinical Build Programmer (Clinical Outcomes Assessment )

Volto Consulting; Indianapolis (IN); On-site; USD 55,000 - 96,000; Part time

Job summary

Volto Consulting in Indianapolis is seeking an eCOA Build Programmer for a 6-month contract to design, program and test data collection databases for clinical trials, focusing on eCOA, eSource and data warehouse mappings.

You will collaborate with study teams to translate requirements into system configurations, perform unit testing, and support regulatory submissions while contributing to reusable templates and process improvements.

Qualifications

• Experience designing and programming eCOA or eDC data collection systems.
• Strong knowledge of data standards, databases, and data mapping.
• Proficiency with HTML/CSS/JavaScript for form design and validation.
• Ability to work cross-functionally with study teams and vendors.

Responsibilities

• Gather and influence eCOA design specifications for trial builds.
• Program and test data collection systems and data repository mappings.
• Ensure data warehouse mappings meet study objectives and quality standards.
• Collaborate with Clinical Build Programmer to complete data builds.
• Support regulatory submissions, inspections, and responses.
• Lead cross-BU/TA projects with high complexity.
• Hands-on programming in eCOA, eSource or Direct Data Capture.

Skills

HTML

CSS

JavaScript

Node.js

JSON

SpEL

SQL

MongoDB

GitLab

Data Mapping

Leadership

Communication

Team Collaboration

Tools

MongoDB

GitLab

Job description

eCOA Build Programmer

Location: ~Indianapolis, IN~

Duration: 6 months

The electronic Clinical Outcomes Assessment (eCOA) Build Programmer is responsible for designing, programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth understanding of data technology, data flow, data standards, database programming, normalization and testing. This role will collaborate with study teams to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

Responsibilities

• Gather and influence eCOA design specifications to enable successful trial implementation
• Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
• Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
• Partner with Clinical Build Programmer to ensure complete data build for trial data collection needs
• Provide insights into study level deliverables (i.e., Data Management Plan, Project Plan, database, and observed datasets)
• Support submission, inspection and regulatory response activities
• Lead cross Business Unit/Therapeutic Area projects or programs with high complexity
• Handson experience as programmer in eCOA (electronic Clinical Outcome Assessment) or eDC (electronic data capture), eSource or Direct Data Capture implementation
• Design of electronic CRF screens to capture Clinical data and build on required validations
• Understanding of Clinical Protocol and interpretation of the Clinical terminologies to create or design specifications
• Familiarity with Clinical data tools, technologies, workflow for collecting patient data, testing and validation of system
• Analyse the impact and implement post production changes the Study design
• Data analytics and visualizations
• Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
• Deciding the technology platform (system/database) for data acquisition and aggregation

Languages Needed

• Programming experience with HTML, CSS, JAVASCRIPT, Node.js, JSON, SpEL
• Experience with relational and non-relational database technologies utilizing SQL, Data Functions and Procedures. (e.g., MongoDB)
• Technical proficiency with HTML, Data Mapping, understanding of database structures, etc.
• Experience handling GITLAB utilities
• Quick learner to new trends in technology
• Excellent leadership, communication (written and oral) and interpersonal skills
• Demonstrated leadership in professional setting
• Demonstrated teamwork and collaboration in a professional setting

Role Descriptions: Key Responsibilities

• Review protocols| eCOA requirements| instrument specifications| translations| visit schedules| and edit-check requirements to determine study build scope.
• Configure and program eCOA studies| including questionnaires| diaries| assessments| visit workflows| notifications| user roles| devices| and data transfer settings.
• Translate approved clinical and business requirements into accurate system configurations and maintain end-to-end traceability.
• Prepare and maintain build specifications| configuration documentation| test scripts| validation evidence| release notes| and deployment records.
• Conduct unit testing and support system| integration| user acceptance| regression| and production validation activities.
• Manage defects and change requests| perform impact assessments| troubleshoot configuration and data issues| and coordinate timely resolution with platform or vendor teams.
• Work closely with instrument owners and licensing teams to ensure approved content| scoring rules| copyright requirements| and language versions are implemented correctly.
• Coordinate study build activities across onsite and offshore teams| track milestones| dependencies| risks| and issues| and provide clear status updates to stakeholders.
• Support integrations and data transfers between eCOA platforms and clinical systems such as EDC| IRT| CTMS| data warehouses| and analytics environments.
• Ensure builds comply with approved standard operating procedures| good documentation practices| validation requirements| data privacy expectations| and applicable regulations.
• Support production deployment| study go-live| post-production verification| maintenance releases| study amendments| and study closeout activities.
• Contribute to reusable templates| standards| automation| peer reviews| and continuous improvement of eCOA study build processes.