Senior Clinical Database Designer
New
Flexible remote work arrangement available anywhere within Canada.Full-TimeSenior
Salary100,000 - 140,000 CAD per year
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Job Details
- Experience
- Minimum of 5 years of experience in clinical data management, database design, or a related clinical research function.
- Required Skills
- GCP
Requirements
- Bachelor's degree in Biological Sciences, Computer Science, or a related field.
- Minimum of 5 years of experience in clinical data management, database design, or a related clinical research function.
- At least 2–3 years of hands-on experience developing and configuring clinical databases using Inform, Medidata Rave, or similar EDC platforms.
- Strong knowledge of clinical trial processes, clinical data standards, and database design methodologies.
- Experience working with both paper-based and electronic clinical data collection environments.
- Proficiency in developing data validation specifications, conducting UAT, and supporting data quality management.
- Experience with SAS programming for logical checks, validation routines, and reporting activities.
- Strong understanding of regulatory requirements, industry standards, and Good Clinical Practice (GCP) principles.
- Excellent organizational skills with the ability to manage multiple priorities.
- Strong communication, presentation, and stakeholder management skills.
- Proven ability to work independently within geographically distributed teams.
Responsibilities
- Design, develop, configure, and maintain clinical trial databases and electronic data capture (EDC) systems.
- Review study protocols, reference materials, and project requirements to establish database design timelines.
- Design and review case report forms (CRFs/eCRFs), database schemas, and data validation specifications.
- Develop, coordinate, and oversee User Acceptance Testing (UAT) activities.
- Collaborate with data management teams to define and monitor clinical trial data flow and quality control.
- Review clinical data, manage queries, support issue resolution, and maintain data integrity.
- Assist with medical coding discrepancy resolution, database audits, and regulatory compliance.
- Develop and maintain standard operating procedures and best practices for database design.
- Provide training and technical guidance to study teams on EDC systems and quality processes.
- Develop and test SAS programs for data validation, reporting, and monitoring.
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