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Clinical Database Designer I
Everest Clinical Research
Markham, CAN
Full-time
Entry · 1+ years experience
Hybrid
CAD 50000-100000 yearly / year
Discovered 3 weeks ago
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Key Skills for This Role
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Key Accountabilities
Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems. Design includes, but is not limited to, Case Report Forms (CRF), edit checks, study roles, laboratory, coder, and Randomization and Trial Supply Management (RTSM).
Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems and provide impact assessment for modifications.
Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings.
Set up and configure the development environment for new studies.
Assist the creation of the Database Integration Specification (DIS) with other systems, provide Integration Technical Detail (ITD) as needed, program the integration, and assist the integration test.
Support the Data Manager in investigating and addressing issues related to the database design.
Review study design requirement specifications for assigned projects, ensuring the specifications adhere to EDC platform standards and Everest Standards. Specification includes, but is not limited to, CRF and Visit Map specification, Data Validation Specification (DVS), and Role Configuration Specification (RCS).
Review the protocol and associated reference material and contribute to the development of the database design project timeline. Maintain database design timelines and promote good project management practices.
Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process.
Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training, and/or associated activities.
Participate in EDC vendor’s technical learning and exchange meetings, as well as other internal and external training meetings.
Contribute to the development and maintenance of the company’s database design standard libraries for all EDC systems.
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