Role Overview:This role involves gathering and influencing eCOA design specifications to ensure successful trial implementation. The programmer will be responsible for developing and testing data collection systems and associated data repository mappings for clinical trials, ensuring accuracy and alignment with study objectives.
Key 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.
Required Skills:- Hands-on experience as a programmer in eCOA (electronic Clinical Outcome Assessment) or eDC (electronic data capture), eSource or Direct Data Capture implementation.
- Experience in the design of electronic CRF screens to capture Clinical data and build on required validations.
- Understanding of Clinical Protocol and interpretation of Clinical terminologies to create or design specifications.
- Familiarity with Clinical data tools, technologies, workflow for collecting patient data, testing and validation of systems.
- Ability to analyze the impact and implement post-production changes to study design.
- Proficiency in data analytics and visualizations.
- Ability to articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions.
- Experience in deciding the technology platform (system/database) for data acquisition and aggregation.
- 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, and understanding of database structures.
- Experience handling GITLAB utilities.
- Quick learner to new trends in technology.
- Excellent leadership, communication (written and oral) and interpersonal skills.
- Demonstrated leadership in a professional setting.
- Demonstrated teamwork and collaboration in a professional setting.
