SKILL: eCOA Build Programmer
Location: Mumbai, Pune, Hyderabad, Bangalore
Basic Qualifications: Bachelor’s or Master’s degree in computer science, engineering, medical field, Informatics, Life Sciences, Statistics, Information Technology, with hands-on experience in database programming, or a combination of clinical data management, system validation and data analysis, experience in clinical, pharmaceutical, biotech, CRO or regulatory agency sectors.
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
- Handle pre and post-production changes for trials.
- Partner with translation vendors to implement localized data collection
- 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
- Opportunity to develop and tests new ideas and/or apply innovative solutions that add new value to the portfolio
Skillset:
- Handson experience as programmer in eCOA (electronic Clinical Outcome Assessment) or Rave eDC Study Build Programming with expertise in Custom Functions (CFs).
- Programming experience with HTML, CSS, JAVASCRIPT, Node.js, JSON.
- Experience with relational and non-relational database technologies utilizing SQL, Data Functions and Procedures. (e.g., MongoDB)
- Quick learner to new trends in technology
- Excellent leadership, communication (written and oral) and interpersonal skills
