Clinical Database Designer I

This is a fully remote position, open to applicants in Canada.

📋 Description

• Create clinical databases for new studies according to requirement specifications across various EDC systems.

• Develop Case Report Forms, implement edit checks, establish study roles, and configure laboratory, coder, and RTSM components.

• Execute post go-live modifications to databases and conduct impact assessments.

• Carry out unit testing, facilitate UAT activities, and resolve any UAT issues.

• Establish and configure development environments for new studies.

• Assist in the creation of Database Integration Specifications, provide technical details for integration, program integrations, and support integration testing.

• Aid Data Managers in identifying and resolving database design challenges.

• Evaluate study design specifications to ensure compliance with EDC platform and Everest standards.

• Review protocols and reference materials and contribute to the timelines of database design projects.

• Maintain timelines for database design and advocate for effective project management practices.

• Support Clinical Data Management in strategizing, directing, and overseeing database design and maintenance.

• Adhere to regulatory requirements, industry trends, benchmarking, and best practices in data management and database design.

• Engage in EDC vendor technical learning and exchange meetings as well as other training opportunities.

• Contribute to the development of database design standard libraries for all EDC systems.

• Provide insights for data management procedural documents related to database design.

• Collaborate with Quality Assurance during audits of assigned databases.

• Validate and distribute real-time study monitoring reports to sponsors and internal team members.

• Take part in Clinical Data Management initiatives.

• Design and develop tools that support database design and data management tasks.

⛳️ Requirements

• Bachelor's degree in Biological Sciences or Computer Science.

• At least one year of experience in clinical database design, including developing clinical databases in DFdiscover, InForm, Medidata Rave, Clinical One, and/or other EDC systems.

• Proficient in software programming relevant to the programming languages and design applications utilized in clinical research.

• Strong oral and written communication skills with individuals at all professional and administrative levels.

• Exceptional interpersonal skills in complex team environments.

• Capacity to establish relationships with both internal and external clients.

• Ability to effectively organize and coordinate the activities of information processing personnel.

• Highly organized, capable of working independently, and adept at managing multiple projects/tasks effectively.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• Pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.

• Option for remote work from a home-based office anywhere in Canada in line with the Work from Home policy.