Job Title : Senior eCOA/eDC Clinical Data Programmer
Location : Indianapolis, IN
Role Descriptions: · 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
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· 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
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