Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
Celerion is hiring for a full-time remote Veeva eCOA Database Developer in the United States. Travel is required domestically and/or internationally for this position.
Job Purpose:
Build and administer Celerion databases within the eCOA environment for protocols, eCRF design and build with corresponding edits as well as subsequent database administration such as user access, mid-study changes and data exports/reports. Position will also serve as lead in accepting Veeva eCOA updates/upgrades, ensuring validation and User Acceptance Testing (UAT) is complete per SOP prior to an eCOA change being pushed to the production instance. Responsible for working collaboratively as programming contact with Clinical Data Managers, Biostatisticians, Clinical and Project Management staff and Sponsors to meet project deliverables, timelines and budgets for eCOA clinical data acquisition, quality checking and reporting while adhering to relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.
Essential Functions:
Perform all activities related to eCOA design and build programming for assigned projects including preparing eCOA specifications and any special licensing that is required for the survey/questionnaire.
Coordinate licensing if needed for any survey/questionnaires.
Create test data / scripts to test both the screen design and validation checks
Create, build and maintain programmatic/functional template libraries and utlilize templates as necessary to speed development
Perform ad-hoc programming support such as listing and reports creation using clinical reporting tools within the eCOA
Provide timely support to the study team on all programming matters according to the project plan and programming specification using internal, standards and guidelines.
Ensure completeness, correctness and consistency of eCOA design, data extracts and listings, and clinical data and data structure
Maintain global clinical trial database standards (CDISC)
Troubleshoot problems on eCOA system, escalate to IT and vendor as needed
Manage the deployment of eCOA trials and setup interface connections between eCOA and other systems, including complex deployments and study specific configurations
Contribute to special projects to meet the business needs from internal and external groups
Author and review procedures and work instructions
Coordinate upgrades of hardware/software including validation documentation development, review and execution
Setup test system environments and coordinate project team members for execution of test scripts
Create validation documentation according to Celerion SOPs and move these documents through the completion, review and approval process
Knowledge/Skills/Education/Licenses:
Bachelor’s degree in related field preferred
3 years or equivalent experience in clinical research using eCOA-like systems to collect data and report
Excellent computer skills with understanding of clinical systems and data administration
Ability to program using appropriate languages such as JSON
Ability to organize and manage multiple concurrent priorities required
Excllent oral and written communication required
Excellent organizational skills required
Problem solving skills required
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
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