Senior Clinical Database Designer

Senior Clinical Database Designer

We are seeking a committed, skilled, and customer-focused individual to join our winning team in Toronto/Markham, Ontario, Canada (on-site) or remotely from anywhere in Canada.

• Develop new features and functionality within the database design functional areas to increase efficiency of database design at the study level and improve our database design capabilities.
• Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process.
• Review the protocol and associated study reference materials to develop the clinical database design project timeline, maintain timelines, and promote good project management practices.
• Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design through relevant training and association activities.
• Design and review case report forms (CRFs/eCRFs) and set up electronic data capture (EDC) systems for clinical trials.
• Author and review Data Validation Specifications for assigned projects.
• Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers; coordinate and oversee the UAT process.
• Design and review patient CRFs and database schema; test data capture screens through UAT.
• Participate in EDC vendor technical learning and exchange meetings as well as other internal and external training meetings.
• Participate in trial investigators meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control Processes.
• Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systems.
• Provide input to all data management procedural documents.
• Plan, manage, control, and perform data processing activities for assigned projects in a timely and accurate manner and in compliance with trial sponsor requirements.
• Review the Data Management Plan (DMP) for assigned projects.
• Review data, issue and resolve queries; assist the Lead Data Manager, sponsor or investigative site in resolving queries.
• Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
• Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases; validate and disseminate real-time study monitoring reports to sponsor and internal team members.
• Define and monitor clinical trial data flow and quality control processes in accordance with corporate SOPs, Good Working Practices, and unit guidelines.
• Accurately and efficiently validate electronically captured data, write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.
• Participate in and contribute to Clinical Data Management initiatives.
• Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports.

• B.Sc. in Biological Sciences or Computer Science.
• Five years of related experience.
• Two to three years developing Inform and/or Medidata Rave (or similar) clinical databases; previous experience in paper-based and electronic data capture systems.
• Effective oral and written communication skills at all professional levels.
• Proven leadership and interpersonal skills in complex team situations.
• Excellent presentation skills and ability to build relationships with internal and external clients.
• Well organized and able to work independently while managing multiple projects/tasks.
• Demonstrated ability to organize and integrate activities of information processing personnel.

We offer a robust benefits package that supports health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), pension plan, generous paid time off and sick leave, and a performance‑based bonus opportunity. Estimated salary range: $100,000 – $140,000.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request will provide accommodations for candidates during recruitment and selection.