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
Hands-on 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
Numbers & Facts
Location
Indianapolis, IN
Skills
Analysis Skillsunmatched
CSS (Cascading Style Sheet)unmatched
Case Report Form (CRF)unmatched
Clinical Dataunmatched
Clinical Data Collectionunmatched
Clinical Outcomesunmatched
Clinical Practices/Protocolsunmatched
Communication Skillsunmatched
Computer Programmingunmatched
Data Analysisunmatched
Data Collectionunmatched
Data Managementunmatched
Data Mappingunmatched
Data Setsunmatched
Data Structuresunmatched
Data Visualizationunmatched
Data Warehousingunmatched
Database Technologyunmatched
Electronic Data Capture (EDC)unmatched
Electronic Designunmatched
Equal Credit Opportunity Act (ECOA)unmatched
HTML (HyperText Markup Language)unmatched
Interpersonal Skillsunmatched
JSONunmatched
JavaScriptunmatched
Leadershipunmatched
MongoDBunmatched
Node.jsunmatched
Presentation/Verbal Skillsunmatched
Project Planningunmatched
Regulationsunmatched
Relational Databases (RDBMS)unmatched
Requirements Managementunmatched
SQL (Structured Query Language)unmatched
System Validationunmatched
Team Playerunmatched
Test Dataunmatched
Validation Testingunmatched
eSourcingunmatched
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